A Phase 3 interventional study of Placebo and Ziprasidone Oral Capsule in Bipolar Mania and Bipolar Disorder, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 108 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (part of Viatris Inc.) · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's enrollment of 584 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 434 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
First submitted before Pfizer's Upjohn has merged with Mylan to form Viatris Inc. became part of Viatris Inc..
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Adults meeting (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)
Exclusion Criteria:
Ultra rapid cyclers and subjects with significant cardiovascular disease including history of and/or congenital long QT syndrome
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active treatment, double-blind, randomized arm
Drug: Ziprasidone Oral Capsule
Placebo treatment, double-blind, randomized arm
Drug: Placebo
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.
Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.
Also known as: Geodon, Zeldox
Time to Intervention for a Mood Episode During Double Blind Period
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
Time frame: Period 2: 24 weeks or time of early termination
Time to Discontinuation for Any Reason During Double Blind Period 2
Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.
Time frame: Period 2: 24 weeks or time of early termination
Modified Time to Intervention for a Mood Episode (TIME)
Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
Time frame: Period 2: Week 24 or time of early termination
Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period
Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period
Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.
Time frame: Period 2: Weeks 1 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)
Time frame: Period 2: Weeks 4 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).
Time frame: Period 2: Weeks 4 - 24 or time of early termination
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).
Time frame: Period 2: Weeks 4 - 24 or time of early termination
Trial intended to be outpatient trial. Patients hospitalized at the screening visit due to disease under study were to be stable enough for outpatient status within approximately 5 days.
| Milestone | Period 1 Open Label Ziprasidone | Ziprasidone | Placebo |
|---|---|---|---|
| Started | 584 | 0 | 0 |
| Completed | 241 | 0 | 0 |
| Not completed | 343 | 0 | 0 |
| Withdrew: Lack of efficacy | 31 | 0 | 0 |
| Withdrew: Laboratory abnormality | 3 | 0 | 0 |
| Withdrew: Adverse event | 148 | 0 | 0 |
| Withdrew: Lost to follow-up | 35 | 0 | 0 |
| Withdrew: Withdrawal by subject | 76 | 0 | 0 |
| Withdrew: Miscellaneous | 50 | 0 | 0 |
| Milestone | Period 1 Open Label Ziprasidone | Ziprasidone | Placebo |
|---|---|---|---|
| Started | 0 | 127 | 111 |
| Completed | 0 | 84 | 54 |
| Not completed | 0 | 43 | 57 |
| Withdrew: Lack of efficacy | 0 | 9 | 22 |
| Withdrew: Laboratory abnormality | 0 | 1 | 0 |
| Withdrew: Adverse event | 0 | 11 | 15 |
| Withdrew: Lost to follow-up | 0 | 3 | 6 |
| Withdrew: Withdrawal by subject | 0 | 9 | 9 |
| Withdrew: Miscellaneous | 0 | 10 | 5 |
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
| Days | Ziprasidone | Placebo |
|---|---|---|
| Time to Intervention for a Mood Episode During Double Blind Period | 172.159 ± 5.646 | 143.133 ± 7.532 |
Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.
| days | Ziprasidone | Placebo |
|---|---|---|
| Time to Discontinuation for Any Reason During Double Blind Period 2 | 153.526 ± 6.454 | 123.313 ± 7.524 |
Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
| Days | Ziprasidone | Placebo |
|---|---|---|
| Modified Time to Intervention for a Mood Episode (TIME) | 168.145 ± 5.857 | 140.325 ± 7.627 |
Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 1 (n=121, 106) | -0.2 ± 3.0 | 0.8 ± 5.1 |
| Week 2 (n=116, 95) | -0.4 ± 4.2 | -0.1 ± 4.7 |
| Week 4 (n=117,95) | -0.6 ± 3.7 | 0.2 ± 5.4 |
| Week 8 (n=107, 79) | -0.3 ± 5.7 | 0.8 ± 5.4 |
| Week 12 (n=98, 70) | -1.0 ± 4.3 | 1.2 ± 8.2 |
| Week 16 (n=94,65) | -1.4 ± 4.3 | 1.2 ± 6.3 |
| Week 20 (n=84, 58) | -1.1 ± 6.5 | 0.2 ± 5.1 |
| Week 24 (n=85,53) | -1.1 ± 5.5 | 0.3 ± 4.2 |
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 1 (n=122, 106) | 0.1 ± 0.7 | 0.3 ± 1.0 |
| Week 2 (n=117, 95) | 0.2 ± 0.9 | 0.2 ± 1.0 |
| Week 4 (n=117, 95) | -0.0 ± 0.7 | 0.1 ± 0.9 |
| Week 8 (n=107, 79) | -0.0 ± 0.8 | -0.1 ± 0.8 |
| Week 12 (n=98, 70) | -0.1 ± 0.9 | 0.0 ± 1.1 |
| Week 16 (n=94, 65) | -0.1 ± 0.9 | 0.0 ± 1.1 |
| Week 20 (n=83, 58) | -0.1 ± 0.9 | -0.2 ± 1.0 |
| Week 24 (n=85, 53) | -0.2 ± 1.0 | -0.2 ± 1.0 |
Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 1 (n=122, 106) | 2.3 ± 1.2 | 2.8 ± 1.6 |
| Week 2 (n=117, 95) | 2.4 ± 1.4 | 2.6 ± 1.6 |
| Week 4 (n=117, 95 | 2.3 ± 1.2 | 2.5 ± 1.5 |
| Week 8 (n=107, 79) | 2.3 ± 1.4 | 2.2 ± 1.2 |
| Week 12 (n=98, 70) | 2.2 ± 1.3 | 2.2 ± 1.4 |
| Week 16 (n=94, 65) | 2.3 ± 1.4 | 2.5 ± 1.5 |
| Week 20 (n=83, 58) | 2.1 ± 1.4 | 2.1 ± 1.4 |
| Week 24 (n=85, 53) | 2.2 ± 1.3 | 2.2 ± 1.4 |
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 1 (n=121, 106) | -0.2 ± 4.9 | 2.7 ± 7.3 |
| Week 2 (n=117, 95) | 1.1 ± 7.4 | 2.7 ± 7.1 |
| Week 4 (n=117, 95) | -0.3 ± 5.3 | 1.6 ± 6.0 |
| Week 8 (n=107, 79) | 0.4 ± 5.9 | 0.4 ± 5.3 |
| Week 12 (n=98, 70) | 1.1 ± 5.9 | 0.6 ± 5.4 |
| Week 16 (n=94,65) | 1.2 ± 6.3 | 0.4 ± 3.9 |
| Week 20 (n=84, 58) | 0.5 ± 5.6 | -0.2 ± 4.9 |
| Week 24 (n=85, 53) | 0.4 ± 6.4 | 1.0 ± 6.5 |
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 4 (n=123, 98) | 0.4 ± 8.7 | 1.5 ± 6.9 |
| Week 8 (n=107, 79) | -0.1 ± 8.3 | -0.8 ± 6.0 |
| Week 12 (n=98, 70) | -0.1 ± 6.5 | 0.3 ± 9.4 |
| Week 16 (n=94, 65) | -0.0 ± 7.1 | 0.7 ± 8.7 |
| Week 20 (n=84, 58) | -0.2 ± 7.4 | -1.0 ± 6.1 |
| Week 24 (n=85, 53) | -0.6 ± 8.0 | -0.9 ± 7.4 |
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 4 (n=123, 98) | 0.0 ± 1.6 | 0.1 ± 1.4 |
| Week 8 (n=107, 79) | -0.2 ± 2.0 | -0.2 ± 1.9 |
| Week 12 (n=98, 70) | -0.3 ± 1.7 | 0.3 ± 3.3 |
| Week 16 (n=94, 65) | -0.4 ± 1.8 | 0.0 ± 2.1 |
| Week 20 (n=84, 58) | -0.2 ± 2.2 | -0.1 ± 2.1 |
| Week 24 (n=85, 53) | -0.2 ± 2.2 | -0.1 ± 2.1 |
Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).
| scores on scale | Ziprasidone | Placebo |
|---|---|---|
| Week 4 (n=123, 98) | 0.2 ± 3.1 | 0.4 ± 2.2 |
| Week 8 (n=107, 79) | 0.2 ± 3.2 | -0.1 ± 1.8 |
| Week 12 (n=98, 70) | 0.1 ± 2.5 | 0.1 ± 2.1 |
| Week 16 (n=94, 65) | 0.3 ± 3.1 | 0.4 ± 2.6 |
| Week 20 (n=84, 58) | -0.0 ± 2.3 | -0.4 ± 1.8 |
| Week 24 (n=85, 53) | -0.1 ± 2.6 | -0.1 ± 2.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1 Open Label Ziprasidone | — | — | — |
| Ziprasidone | — | — | — |
| Placebo | — | — | — |
| Event | Period 1 Open Label Ziprasidone | Ziprasidone | Placebo |
|---|---|---|---|
| ManiaPsychiatric disorders | 2/584 | 0/127 | 2/112 |
| Suicidal ideationPsychiatric disorders | 2/584 | 2/127 | 0/112 |
| ArrhythmiaCardiac disorders | 0/584 | 1/127 | 0/112 |
| Bipolar disorderPsychiatric disorders | 2/584 | 0/127 | 0/112 |
| InfluenzaInfections and infestations | 1/584 | 0/127 | 0/112 |
| DystoniaNervous system disorders | 1/584 | 0/127 | 0/112 |
| PregnancyPregnancy, puerperium and perinatal conditions | 1/584 | 0/127 | 0/112 |
| Affect labilityPsychiatric disorders | 1/584 | 0/127 | 0/112 |
| AnxietyPsychiatric disorders | 1/584 | 0/127 | 0/112 |
| Bipolar I disorderPsychiatric disorders | 1/584 | 0/127 | 0/112 |
| Event | Period 1 Open Label Ziprasidone | Ziprasidone | Placebo |
|---|---|---|---|
| SedationNervous system disorders | 134/584 | 0/127 | 0/112 |
| SomnolenceNervous system disorders | 99/584 | 0/127 | 0/112 |
| TremorNervous system disorders | 73/584 | 8/127 | 4/112 |
| InsomniaPsychiatric disorders | 59/584 | 7/127 | 12/112 |
| DizzinessNervous system disorders | 49/584 | 0/127 | 0/112 |
| AkathisiaNervous system disorders | 47/584 | 0/127 | 0/112 |
| FatigueGeneral disorders | 44/584 | 0/127 | 0/112 |
| NauseaGastrointestinal disorders | 42/584 | 0/127 | 0/112 |
| HeadacheNervous system disorders | 32/584 | 0/127 | 0/112 |
| Upper respiratory tract infectionInfections and infestations | 0/584 | 5/127 | 6/112 |
| Age, Continuous(years) | Ziprasidone | Placebo | Total |
|---|---|---|---|
| Mean | 39.6 ± 12.3 | 38.0 ± 11.6 | 38.4 ± 11.8 |
| Sex: Female, Male(Participants) | Ziprasidone | Placebo | Total |
|---|---|---|---|
| Female | 51 | 58 | 109 |
| Male | 76 | 53 | 129 |
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ziprasidone
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. →