Phase 3
Completed N=504
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
Source: ClinicalTrials.gov NCT00141271 ↗Enrolled (actual)
504
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score — -6.07; -7.66; -5.75; -10.12 score on scale — p=0.6409
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 |
-6.07; -7.66; -5.75; -10.12; -10.20; -9.47 | 0.6409 |
| SECONDARY Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score |
19; 32; 26; 142; 121; 133 | 0.2287 |
| SECONDARY Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score |
60; 67; 61; 87; 82; 87 | 0.8921 |
| SECONDARY Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) |
10.11; 11.72; 11.19 | 0.4327 |
| SECONDARY Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 |
18; 27; 25; 143; 126; 134 | 0.2076 |
| SECONDARY Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 |
27; 30; 35; 120; 119; 113 | 0.3888 |
| SECONDARY Change in Hamilton Depression (HAM-D 17) Total Score |
-9.56; -10.58; -10.13; -12.37; -12.82; -11.30 | 0.4869 |
| SECONDARY Change in Hamilton Anxiety Rating (HAM-A) |
-5.54; -6.46; -6.79; -7.63; -7.46; -6.73 | 0.0896 |
| SECONDARY Change in Total Score of Young Mania Rating Scale (YMRS) |
0.05; 0.64; -0.08; 0.16; 0.64; 0.51 | 0.6924 |
| SECONDARY Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) |
-0.05; -0.47; -0.42; -0.84; -0.82; -0.75 | 0.2878 |
| SECONDARY Change in Global Clinical Improvement of Symptoms (CGI -I) |
3.34; 3.17; 3.38; 2.86; 2.82; 3.01 | 0.6932 |
| SECONDARY Change in Total Score in Hamilton Depression (HAM-D 25) |
-11.02; -12.16; -12.25; -14.59; -15.08; -13.74 | 0.2058 |
| SECONDARY Response as Measured by CGI-I Score Less Than or Equal to 2 |
20; 34; 28; 142; 118; 130 | 0.1454 |
| SECONDARY Change in Sheehan Disability Scale (SDS) Total Score at Endpoint |
-5.78; -5.43; -6.79 | 0.3299 |
| SECONDARY Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint |
0.08; 0.09; 0.09 | 0.5407 |
| SECONDARY Change in Bech Melancholia Score |
-5.12; -5.61; -5.22; -6.91; -6.93; -6.23 | 0.8464 |
| SECONDARY Change in Anxiety/Somatizations Factor Total Score |
-2.69; -2.92; -2.98; -3.67; -3.88; -3.62 | 0.3355 |
| SECONDARY Change in Retardation Factor Scores |
-3.50; -3.64; -3.59; -4.44; -4.40; -3.79 | 0.7758 |
| SECONDARY Change in Sleep Disturbance Factor Score |
-1.92; -2.07; -1.96; -2.20; -2.19; -2.06 | 0.8598 |
| SECONDARY Change in Verbal Memory Trial Performance Total Score at Endpoint |
1.31; 0.85; 1.22 | 0.9260 |
| SECONDARY Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint |
-0.28; -0.30; -0.06 | 0.1836 |
| SECONDARY Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint |
-0.02; 0.14; -0.00 | 0.9237 |
| SECONDARY Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint |
-0.09; -0.05; 0.05 | 0.4624 |
| SECONDARY Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint |
-0.16; 0.07; 0.13 | 0.1378 |
| SECONDARY Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint |
-0.18; -0.30; -0.03 | 0.4767 |
| SECONDARY Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint |
-0.52; -0.15; -0.24 | 0.1667 |
| SECONDARY Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint |
-0.39; -0.01; -0.32 | 0.7019 |
| SECONDARY Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint |
-0.06; -0.07; 0.08 | 0.4749 |
| SECONDARY Change in Digit Sequencing Task at Endpoint |
0.76; 0.09; 0.46 | 0.4398 |
| SECONDARY Change in Token Motor Task at Endpoint |
0.28; -0.00; 2.02 | 0.2763 |
| SECONDARY Change in Verbal Fluency in Naming Categories at Endpoint |
0.19; -0.11; -0.28 | 0.4340 |
| SECONDARY Change in Verbal Fluency Controlled Word Association at Endpoint |
1.09; -0.15; 1.54 | 0.5195 |
| SECONDARY Change in Symbol Coding at Endpoint |
1.34; 1.07; 2.66 | 0.2847 |
| SECONDARY Change in Tower of London Test at Endpoint |
0.31; 0.68; 0.91 | 0.1652 |
| SECONDARY Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint |
-0.37; 0.15; 0.23 | 0.0082 sig |
| SECONDARY Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint |
0.09; 0.01; -0.03 | 0.2718 |
| SECONDARY Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint |
-0.18; -0.24; -0.02 | 0.5057 |
| SECONDARY Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint |
0.06; 0.19; 0.14 | 0.6227 |
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 Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (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 not otherwise specified (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 (NCT00141271). 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.