A Phase 3 interventional study of Armodafinil in Depression, sponsored by Cephalon. Terminated at 158 sites in 17 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-21.
Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults 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 867 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.
Key Inclusion Criteria:
During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
Key Exclusion Criteria:
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. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
Drug: Armodafinil
Armodafinil tablets, taken orally, once daily in the morning
Also known as: CEP-10953, Nuvigil
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 up to Month 6
Participants With Clinically Significant Abnormal Serum Chemistry Values
Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. * ULN=upper limit of normal * BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women. * GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L * ALT = alanine aminotransferase with a normal range of 6-43 U/L * BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L * AST = aspartate aminotransferase with a normal range of 9-36 U/L
Time frame: Day 1 to Month 6
Participants With Clinically Significant Abnormal Hematology Values
Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. * ULN=upper limit of normal * WBC - white blood cell counts with a normal range of 3.8-10.7 10\^9/L. * Hemoglobin with a normal range of 115-181 g/L * Hematocrit with a normal range of 0.34-0.54 L/L * Platelet counts with a normal range of 130-400 10\^9/L * ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10\^9/L
Time frame: Day 1 to Month 6
Participants With Clinically Significant Abnormal Urinalysis Values
Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was \>=2 unit increase from baseline.
Time frame: Day 1 to Month 6
Participants With Clinically Significant Abnormal Vital Signs Values
Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria: * Pulse high: \>=120 beats per minute (bpm) and increase of \>=15 bpm from baseline * Pulse low: \<=50 bpm and decrease of \>=15 bpm from baseline * Sitting systolic blood pressure high: \>=180 mm Hg and increase of \>=20 mm Hg from baseline * Sitting systolic blood pressure low: \<=90 mm Hg and decrease of \>=20 mm Hg from baseline * Sitting diastolic blood pressure high: \>=105 mm Hg and increase of \>=15 mm Hg from baseline * Sitting diastolic blood pressure low: \<=50 mm Hg and decrease of \>=15 mm Hg from baseline
Time frame: Day 1 to Month 6
Change From Baseline to Endpoint in Electrocardiogram (ECG) Values
ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination). RR= inter-beat intervals
Time frame: Day 0 (baseline), Month 6 or last post-baseline observation
Physical Examination Shifts From Baseline to Endpoint
Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint. HEENT = Head, Eye, Ear, Nose and Throat exam
Time frame: Day 0 (baseline), Month 6 (or last post-baseline observation)
Change From Baseline to Endpoint in Body Weight
Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Month 6 (or last post-baseline observation)
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. Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Month 6 or last post-baseline observation
Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)
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 number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated. - C-SSRS=Columbia Suicide Severity Rating Scale
Time frame: Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit
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. Baseline was the assessment before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Month 6 (or last post-baseline observation)
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. Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Month 6 or last post-baseline observation
Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint 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. Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint 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. Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint 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. Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)
Change From Baseline to 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. Baseline was the score before the first dose of study drug in the double-blind study.
Time frame: Day 0 (baseline), Month 6 or the last post-baseline assessment)
| Milestone | Armodafinil 150-200 mg/Day |
|---|---|
| Started | 867 |
| Safety population | 863 |
| Full analysis population | 859 |
| Completed | 506 |
| Not completed | 361 |
| Withdrew: Adverse event | 63 |
| Withdrew: Lack of efficacy | 35 |
| Withdrew: Withdrawal by subject | 65 |
| Withdrew: Protocol violation | 20 |
| Withdrew: Noncompliance with study medication | 12 |
| Withdrew: Noncompliance with study procedures | 9 |
| Withdrew: Lost to follow-up | 39 |
| Withdrew: Other | 118 |
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 | Armodafinil 150-200 mg/Day |
|---|---|
| >=1 adverse event | 423 |
| Severe adverse event | 26 |
| Treatment-related adverse event | 219 |
| Deaths | 0 |
| Other serious adverse events | 27 |
| Withdrawn from study due to adverse events | 57 |
| Protocol-defined adverse events | 19 |
Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. * ULN=upper limit of normal * BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women. * GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L * ALT = alanine aminotransferase with a normal range of 6-43 U/L * BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L * AST = aspartate aminotransferase with a normal range of 9-36 U/L
| participants | Armodafinil 150-200 mg/Day |
|---|---|
| >=1 clinical significant value | 41 |
| Uric Acid, M>=625, F>=506 μmol/L | 17 |
| GGT, >=3*ULN | 16 |
| ALT, >=3*ULN | 7 |
| BUN, >=10.71 mmol/L | 7 |
| AST, >=3*ULN | 3 |
Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. * ULN=upper limit of normal * WBC - white blood cell counts with a normal range of 3.8-10.7 10\^9/L. * Hemoglobin with a normal range of 115-181 g/L * Hematocrit with a normal range of 0.34-0.54 L/L * Platelet counts with a normal range of 130-400 10\^9/L * ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10\^9/L
| participants | Armodafinil 150-200 mg/Day |
|---|---|
| >=1 clinical significant value | 13 |
| WBC, <=3*10^9/L | 5 |
| Hemoglobin, M<=115, F<=95 g/L | 4 |
| Hematocrit, M<0.37, F<0.32 L/L | 8 |
| Platelets, <=75*10^9/L | 1 |
| ANC, <=1*10^9/L | 2 |
Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was \>=2 unit increase from baseline.
| participants | Armodafinil 150-200 mg/Day |
|---|---|
| >=1 clinical significant value | 28 |
| Urine hemoglobin | 22 |
| Urine glucose | 2 |
| Ketones | 2 |
| Urine total protein | 2 |
Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria: * Pulse high: \>=120 beats per minute (bpm) and increase of \>=15 bpm from baseline * Pulse low: \<=50 bpm and decrease of \>=15 bpm from baseline * Sitting systolic blood pressure high: \>=180 mm Hg and increase of \>=20 mm Hg from baseline * Sitting systolic blood pressure low: \<=90 mm Hg and decrease of \>=20 mm Hg from baseline * Sitting diastolic blood pressure high: \>=105 mm Hg and increase of \>=15 mm Hg from baseline * Sitting diastolic blood pressure low: \<=50 mm Hg and decrease of \>=15 mm Hg from baseline
| participants | Armodafinil 150-200 mg/Day |
|---|---|
| >=1 clinical significant value | 19 |
| Pulse high | 2 |
| Pulse low | 2 |
| Sitting systolic blood pressure high | 3 |
| Sitting systolic blood pressure low | 8 |
| Sitting diastolic blood pressure high | 5 |
| Sitting diastolic blood pressure low | 2 |
ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination). RR= inter-beat intervals
| msec | Armodafinil 150-200 mg/Day |
|---|---|
| PR interval | 0.2 ± 16.60 |
| QRS interval | 0.0 ± 7.03 |
| QT interval | 1.4 ± 25.66 |
| QTc interval Bazett | 2.2 ± 19.50 |
| QTc interval Fredericia | 1.9 ± 15.36 |
| RR interval | -2.2 ± 137.98 |
Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint. HEENT = Head, Eye, Ear, Nose and Throat exam
| participants | Armodafinil 150-200 mg/Day |
|---|---|
| General appearance; normal/normal | 714 |
| General appearance; normal/abnormal | 8 |
| General appearance; abnormal/normal | 23 |
| General appearance; abnormal/abnormal | 40 |
| HEENT: normal/normal | 753 |
| HEENT: normal/abnormal | 3 |
| HEENT: abnormal/normal | 15 |
| HEENT: abnormal/abnormal | 13 |
| Chest+lungs: normal/normal | 780 |
| Chest+lungs: normal/abnormal | 0 |
| Chest+lungs: abnormal/normal | 5 |
| Chest+lungs: abnormal/abnormal | 0 |
| Heart: normal/normal | 781 |
| Heart: normal/abnormal | 2 |
| Heart: abnormal/normal | 1 |
| Heart: abnormal/abnormal | 1 |
| Abdomen: normal/normal | 751 |
| Abdomen: normal/abnormal | 5 |
| Abdomen: abnormal/normal | 16 |
| Abdomen: abnormal/abnormal | 13 |
| Musculoskeletal: normal/normal | 756 |
| Musculoskeletal: normal/abnormal | 7 |
| Musculoskeletal: abnormal/normal | 11 |
| Musculoskeletal: abnormal/abnormal | 11 |
| Skin: normal/normal | 707 |
| Skin: normal/abnormal | 9 |
| Skin: abnormal/normal | 41 |
| Skin: abnormal/abnormal | 28 |
| Lymph nodes: normal/normal | 779 |
| Lymph nodes: normal/abnormal | 0 |
| Lymph nodes: abnormal/normal | 0 |
| Lymph nodes: abnormal/abnormal | 1 |
| Neurological: normal/normal | 777 |
| Neurological: normal/abnormal | 2 |
| Neurological: abnormal/normal | 2 |
| Neurological: abnormal/abnormal | 3 |
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. Baseline was the score before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Week 1 (837) | -23.7 ± 12.10 |
| Month 1 (793) | -25.8 ± 11.61 |
| Month 2 (716) | -27.6 ± 11.38 |
| Month 4 (578) | -29.2 ± 11.68 |
| Month 6 (503) | -29.7 ± 12.06 |
| Endpoint (857) | -27.5 ± 13.08 |
Baseline was the score before the first dose of study drug in the double-blind study.
| kg | Armodafinil 150-200 mg/Day |
|---|---|
| Change From Baseline to Endpoint in Body Weight | -0.8 ± 5.67 |
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. Baseline was the score before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score | -0.7 ± 4.28 |
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 number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated. - C-SSRS=Columbia Suicide Severity Rating Scale
| participants | Armodafinil 150-200 mg/Day |
|---|---|
| Suicidal behavior - Actual attempt | 1 |
| Non-suicidal self-injurious behaviour | 1 |
| Suicidal behavior - Interrupted attempt | 0 |
| Suicidal behavior - Aborted attempt | 0 |
| Suicidal behavior - suicidal behavior | 0 |
| Suicidal behavior - Preparatory acts/behavior | 1 |
| Suicidal behavior - Completed suicide | 0 |
| Suicidal ideation - Wish to be dead | 15 |
| Non-specific active suicidal thoughts | 4 |
| Any methods (not plan) w/o intent to act | 2 |
| Some intent to act, w/o specific plan | 1 |
| Suicidal ideation - Specific plan and intent | 1 |
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. Baseline was the score before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Week 1 (838) | -9.3 ± 4.68 |
| Month 1 (793) | -10.0 ± 4.47 |
| Month 2 (716) | -10.6 ± 4.52 |
| Month 4 (578) | -11.1 ± 4.70 |
| Month 6 (503) | -11.3 ± 4.69 |
| Endpoint (857) | -10.6 ± 5.07 |
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. Baseline was the score before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Week 1 (838) | -1.7 ± 1.17 |
| Month 1 (791) | -1.9 ± 1.17 |
| Month 2 (716) | -2.0 ± 1.18 |
| Month 4 (578) | -2.2 ± 1.16 |
| Month 6 (502) | -2.3 ± 1.18 |
| Endpoint (859) | -2.0 ± 1.31 |
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. Baseline was the score before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale | 17.7 ± 13.61 |
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. Baseline was the assessment before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score | -9.1 ± 7.66 |
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. Baseline was the score before the first dose of study drug in the double-blind study.
| units on a scale | Armodafinil 150-200 mg/Day |
|---|---|
| Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score | -6.2 ± 5.68 |
Collected over Day 1 up to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Armodafinil 150-200 mg/Day | — | 27/863 (3.1%) | 133/863 (15.4%) |
| Event | Armodafinil 150-200 mg/Day |
|---|---|
| ManiaPsychiatric disorders | 5/863 |
| Bipolar I disorderPsychiatric disorders | 3/863 |
| Suicidal ideationPsychiatric disorders | 3/863 |
| Angina pectorisCardiac disorders | 1/863 |
| Myocardial infarctionCardiac disorders | 1/863 |
| Torsade de pointesCardiac disorders | 1/863 |
| ColitisGastrointestinal disorders | 1/863 |
| DiarrhoeaGastrointestinal disorders | 1/863 |
| Cholecystitis acuteHepatobiliary disorders | 1/863 |
| LaryngitisInfections and infestations | 1/863 |
| Event | Armodafinil 150-200 mg/Day |
|---|---|
| HeadacheNervous system disorders | 96/863 |
| InsomniaPsychiatric disorders | 49/863 |
All participants
| Age, Continuous(years) | Armodafinil 150-200 mg/Day |
|---|---|
| Mean | 44.2 ± 10.96 |
| Sex: Female, Male(Participants) | Armodafinil 150-200 mg/Day |
|---|---|
| Female | 525 |
| Male | 342 |
| Ethnicity (NIH/OMB)(Participants) | Armodafinil 150-200 mg/Day |
|---|---|
| Hispanic or Latino | 91 |
| Not Hispanic or Latino | 752 |
| Unknown or Not Reported | 24 |
| Race (NIH/OMB)(Participants) | Armodafinil 150-200 mg/Day |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 118 |
| White | 709 |
| More than one race | 0 |
| Unknown or Not Reported | 28 |
| Weight(kg) | Armodafinil 150-200 mg/Day |
|---|---|
| Mean | 83.7 ± 19.75 |
| Height(cm) | Armodafinil 150-200 mg/Day |
|---|---|
| Mean | 168.8 ± 9.54 |
| Body Mass Index(kg/m^2) | Armodafinil 150-200 mg/Day |
|---|---|
| Mean | 29.4 ± 6.43 |
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Studies of the drug tested here: Modafinil