A Phase 3 interventional study of Armodafinil and Placebo in Depression, sponsored by Cephalon. Completed at 130 sites in 14 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 399 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Cephalon is the lead sponsor of 75 studies on the registry; none are open to participants now.
First submitted before Cephalon became part of Teva Pharmaceutical Industries, Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
Drug: Placebo
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
Drug: Armodafinil
Armodafinil tablets, taken orally, once daily in the morning
Also known as: Nuvigil, CEP-10953
Matching placebo tablets, taken orally, once daily in the morning
Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Time frame: Day 0 (baseline), Week 8
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Time frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Time frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Time frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
Time frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
Time frame: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)
Participants With Treatment-Emergent Adverse Events (TEAE)
AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.
Time frame: Day 1 to Week 9
Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Time frame: Day 0 (baseline), last postbaseline observation (up to 8 weeks)
Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
Time frame: Day 0 (baseline), last postbaseline observation (up to 8 weeks)
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
Time frame: Day 0 (baseline), last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.
Time frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Region 1: USA and Canada Region 2: Eastern European countries, Kyrgyzstan, Mongolia, Uzbekistan, Cyprus, Greece, and Turkey Region 3: Central and Northern European countries, Andorra, Australia, Iceland, Monaco, San Marino, and Vatican City Region 4: Rest of World
| Milestone | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Started | 199 | 200 |
| Safety population | 198 | 200 |
| Full analysis population | 196 | 197 |
| Completed | 167 | 169 |
| Not completed | 32 | 31 |
| Withdrew: Adverse event | 10 | 7 |
| Withdrew: Lack of efficacy | 3 | 4 |
| Withdrew: Withdrawal by subject | 9 | 9 |
| Withdrew: Protocol violation | 4 | 6 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Noncompliance with study medication | 0 | 1 |
| Withdrew: Noncompliance with study procedures | 0 | 1 |
| Withdrew: Other | 1 | 0 |
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) | -19.4 ± 0.99 | -20.8 ± 0.99 |
A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
| percentage of participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 2 | 3 |
| Week 2 (187, 189) | 13 | 9 |
| Week 4 (181, 183) | 21 | 27 |
| Week 6 (172, 172) | 29 | 41 |
| Week 7 (167, 170) | 39 | 51 |
| Week 8 (167, 169) | 46 | 56 |
| Endpoint (196, 197) | 41 | 49 |
A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
| percentage of participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | .5 | 1 |
| Week 2 (187, 189) | 2 | 2 |
| Week 4 (181, 183) | 5 | 7 |
| Week 6 (172, 172) | 9 | 12 |
| Week 7 (167, 170) | 14 | 19 |
| Week 8 (167, 169) | 15 | 26 |
| Endpoint (196, 197) | 13 | 22 |
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | -6.0 ± 6.61 | -5.3 ± 7.12 |
| Week 2 (187, 189) | -10.0 ± 8.71 | -8.9 ± 8.56 |
| Week 4 (181, 183) | -13.4 ± 9.87 | -13.5 ± 10.54 |
| Week 6 (172, 172) | -15.8 ± 10.42 | -17.6 ± 11.09 |
| Week 7 (167, 170) | -18.0 ± 11.42 | -20.2 ± 10.88 |
| Week 8 (167, 169) | -19.7 ± 11.30 | -21.6 ± 11.75 |
| Endpoint (196, 197) | -18.3 ± 11.62 | -19.5 ± 12.66 |
The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | -2.4 ± 2.92 | -2.1 ± 3.07 |
| Week 2 (187, 189) | -4.2 ± 3.83 | -3.4 ± 3.63 |
| Week 4 (181, 183) | -5.3 ± 4.05 | -5.3 ± 4.15 |
| Week 6 (172, 172) | -6.3 ± 4.16 | -6.7 ± 4.38 |
| Week 7 (167, 170) | -7.2 ± 4.49 | -7.8 ± 4.35 |
| Week 8 (167, 169) | -8.0 ± 4.53 | -8.3 ± 4.62 |
| Endpoint (196, 197) | -7.3 ± 4.73 | -7.5 ± 4.91 |
The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | -0.2 ± 0.49 | -0.2 ± 0.46 |
| Week 2 (187, 189) | -0.5 ± 0.65 | -0.5 ± 0.77 |
| Week 4 (181, 183) | -0.7 ± 0.76 | -0.9 ± 0.97 |
| Week 6 (172, 172) | -1.0 ± 0.91 | -1.2 ± 1.03 |
| Week 7 (167, 170) | -1.2 ± 1.08 | -1.4 ± 1.10 |
| Week 8 (167, 169) | -1.3 ± 1.11 | -1.6 ± 1.19 |
| Endpoint (196, 197) | -1.2 ± 1.14 | -1.4 ± 1.25 |
The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 4 (181, 183) | 5.8 ± 7.39 | 8.2 ± 10.39 |
| Week 8 (167, 169) | 11.5 ± 10.42 | 15.3 ± 11.72 |
| Endpoint (189, 192) | 10.6 ± 10.42 | 13.6 ± 12.38 |
AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| >=1 adverse event | 71 | 89 |
| Severe adverse event | 4 | 4 |
| Treatment-related adverse event | 32 | 53 |
| Deaths | 0 | 0 |
| Other serious adverse events | 6 | 5 |
| Withdrawn from study due to adverse events | 10 | 7 |
| Protocol-defined adverse events | 3 | 3 |
The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score | -1.0 ± 2.45 | -0.9 ± 3.19 |
HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score | -4.2 ± 4.53 | -4.3 ± 5.37 |
The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
| units on a scale | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score | -7.0 ± 6.62 | -7.1 ± 6.91 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 0 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 0 |
| Week 6 (172, 172) | 0 | 0 |
| Week 7 (167, 170) | 0 | 0 |
| Week 8 (167, 169) | 0 | 0 |
| Endpoint (196, 198) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 6 | 5 |
| Week 2 (187, 189) | 2 | 6 |
| Week 4 (181, 183) | 1 | 7 |
| Week 6 (172, 172) | 2 | 3 |
| Week 7 (167, 170) | 2 | 2 |
| Week 8 (167, 169) | 1 | 3 |
| Endpoint (196, 198) | 2 | 4 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (196, 195) | 2 | 0 |
| Week 2 (187, 189) | 0 | 0 |
| Week 4 (181, 183) | 0 | 1 |
| Week 6 (172, 172) | 0 | 1 |
| Week 7 (167, 170) | 0 | 1 |
| Week 8 (167, 169) | 0 | 1 |
| Endpoint (196, 198) | 0 | 1 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (6, 5) | 1 | 1 |
| Week 2 (2, 6) | 0 | 0 |
| Week 4 (1, 7) | 0 | 0 |
| Week 6 (1, 3) | 0 | 0 |
| Week 7 (2, 2) | 0 | 0 |
| Week 8 (1, 3) | 0 | 0 |
| Endpoint (8, 12) | 1 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (6, 5) | 0 | 0 |
| Week 2 (2, 6) | 0 | 0 |
| Week 4 (1, 7) | 0 | 0 |
| Week 6 (1, 3) | 0 | 0 |
| Week 7 (2, 2) | 0 | 0 |
| Week 8 (1, 3) | 0 | 0 |
| Endpoint (8, 12) | 0 | 0 |
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.
| participants | Placebo | Armodafinil 150 mg/Day |
|---|---|---|
| Week 1 (6, 5) | 1 | 0 |
| Week 2 (2, 6) | 0 | 0 |
| Week 4 (1, 7) | 0 | 0 |
| Week 6 (1, 3) | 0 | 0 |
| Week 7 (2, 2) | 0 | 0 |
| Week 8 (1, 3) | 0 | 0 |
| Endpoint (8, 12) | 1 | 0 |
Collected over Day 1 to Week 9. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Armodafinil 150 mg/Day | — | 5/200 (2.5%) | 37/200 (18.5%) |
| Placebo | — | 6/198 (3%) | 21/198 (10.6%) |
| Event | Armodafinil 150 mg/Day | Placebo |
|---|---|---|
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/200 | 1/198 |
| Unintended pregnancyPregnancy, puerperium and perinatal conditions | 0/200 | 1/198 |
| HypomaniaPsychiatric disorders | 0/200 | 1/198 |
| Suicidal ideationPsychiatric disorders | 0/200 | 1/198 |
| Cervical dysplasiaReproductive system and breast disorders | 0/200 | 1/198 |
| Toxic skin eruptionSkin and subcutaneous tissue disorders | 0/200 | 1/198 |
| Cholecystitis chronicHepatobiliary disorders | 1/200 | 0/198 |
| AnxietyPsychiatric disorders | 1/200 | 0/198 |
| Bipolar I disorderPsychiatric disorders | 1/200 | 0/198 |
| DepressionPsychiatric disorders | 1/200 | 0/198 |
| Event | Armodafinil 150 mg/Day | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 29/200 | 15/198 |
| NauseaGastrointestinal disorders | 12/200 | 7/198 |
Randomized participants
| Age, Continuous(years) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Mean | 43.7 ± 11.62 | 45.3 ± 11.26 | 44.5 ± 11.45 |
| Sex: Female, Male(Participants) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Female | 121 | 120 | 241 |
| Male | 78 | 80 | 158 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 22 | 36 |
| Not Hispanic or Latino | 183 | 176 | 359 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 14 | 30 |
| White | 176 | 182 | 358 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 0 | 6 |
| Weight(kg) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Mean | 81.2 ± 17.46 | 80.7 ± 17.54 | 80.9 ± 17.48 |
| Height(cm) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Mean | 168.4 ± 9.32 | 168.9 ± 9.23 | 168.6 ± 9.27 |
| Body Mass Index(kg/m^2) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Mean | 28.7 ± 5.95 | 28.2 ± 5.52 | 28.4 ± 5.73 |
| Time Since Start of Current Depressive Episode(weeks) | Placebo | Armodafinil 150 mg/Day | Total |
|---|---|---|---|
| Mean | 12.1 ± 9.10 | 12.3 ± 9.89 | 12.2 ± 9.49 |
1 further baseline measures are reported on the registry.
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Studies of the drug tested here: Modafinil