Phase 3
N=680
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00312494 ↗Enrolled (actual)
680
Serious AEs
2.0%
Results posted
Jan 2010
Primary outcome: Primary: Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) — -10.19; -10.95; -9.47 scores on scale — p=0.1077
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Ziprasidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) |
-10.19; -10.95; -9.47 | 0.1077 |
| SECONDARY Change From Baseline to Week 1 and Week 2 in YMRS |
-4.38; -4.56; -5.10; -7.10; -7.56; -8.24 | 0.4025 |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores |
-2.16; -2.47; -1.11; -3.27; -3.24; -1.71 | 0.0101 sig |
| SECONDARY Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score |
-0.35; -0.43; -0.39; -0.70; -0.74; -0.73 | 0.6191 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Scale Scores |
3.34; 3.34; 3.38; 3.02; 2.91; 2.98 | 0.6138 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score |
-4.87; -5.34; -3.44; -1.94; -2.26; -1.56 | 0.1063 |
| SECONDARY Change From Baseline in Global Assessment of Functioning (GAF) Score |
8.79; 9.62; 7.79 | 0.0728 |
| SECONDARY Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score |
-1.68; -1.58; -1.27 | 0.4460 |
| SECONDARY Anonymized Pharmacogenomic Blood Draw |
— | — |
Summary
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
Eligibility Criteria
Inclusion Criteria
- Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
- At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
- Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.
Exclusion Criteria
- Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).
- Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.
Data sourced from ClinicalTrials.gov (NCT00312494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.