Phase 3
Completed N=381
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
Source: ClinicalTrials.gov NCT00282464 ↗Enrolled (actual)
381
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -7.23; -5.02; -9.99; -8.13 score on scale — p=0.002
Summary
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-7.23; -5.02; -9.99; -8.13; -11.88; -10.04 | 0.002 sig |
| SECONDARY Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score |
40; 24; 137; 168; 55; 48 | 0.0056 sig |
| SECONDARY Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score |
72; 65; 95; 112; 85; 91 | 0.2185 |
| SECONDARY Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12 |
41; 21; 136; 168; 54; 41 | 0.0005 sig |
| SECONDARY Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7 |
32; 33; 135; 144; 56; 51 | 0.9863 |
| SECONDARY Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score |
-9.91; -8.73; -12.91; -12.07; -6.92; -7.11 | 0.112 |
| SECONDARY Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25) |
-11.68; -10.76; -15.48; -14.80; -8.06; -8.58 | 0.305 |
| SECONDARY Change in Bech Melancholia Score |
-5.22; -4.28; -6.82; -6.20; -3.73; -3.61 | 0.026 sig |
| SECONDARY Change in Anxiety/Somatizations Factor Total Score |
-2.84; -2.61; -4.09; -3.96; -2.18; -2.57 | 0.381 |
| SECONDARY Change in Retardation Factor Scores |
-3.22; -2.68; -4.38; -3.66; -2.24; -1.88 | 0.068 |
| SECONDARY Change in Sleep Disturbance Factor Score |
-1.51; -1.48; -2.38; -2.31; -1.19; -1.26 | 0.899 |
| SECONDARY Change in Hamilton Anxiety Rating (HAM-A) |
-4.63; -4.18; -6.84; -6.64; -3.05; -3.26 | 0.434 |
| SECONDARY Change in Total Score of Young Mania Rating Scale (YMRS) |
0.40; 0.69; 0.49; -0.13; -0.13; 0.00 | 0.468 |
| SECONDARY Change in Global Clinical Severity of Symptoms (CGI-S) |
-0.39; -0.25; -0.66; -0.51; -0.88; -0.84 | 0.042 sig |
| SECONDARY Change in Global Clinical Improvement of Symptoms (CGI -I) |
3.37; 3.61; 3.09; 3.29; 2.89; 3.04 | 0.0099 sig |
| SECONDARY Change in Global Assessment of Functioning (GAF) |
9.59; 9.53 | 0.965 |
| SECONDARY Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score |
0.06; 0.06 | 0.860 |
| SECONDARY Change in Sheehan Disability Scale (SDS) Total Score |
-3.69; -3.05 | 0.428 |
| SECONDARY Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject |
-0.65; -0.73 | 0.708 |
| SECONDARY Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating |
4.66; 4.68 | 0.898 |
| SECONDARY Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer |
4.72; 4.63 | 0.559 |
| SECONDARY Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint |
4.69; 4.81 | 0.458 |
Eligibility Criteria
Inclusion Criteria
- Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)
Exclusion Criteria
- Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder NOS (298.9).
- Subjects with other DSM-IV TR Axis I or Axis II disorder (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 (NCT00282464). 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. Informational only — not medical advice.