Phase 4
N=30
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Bipolar II Disorder · Major Depressive Episode
Bottom Line
View on ClinicalTrials.gov: NCT00237666 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Jun 2013
Primary outcome: Primary: The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores — 23.1; 10.57 Scores on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ziprasidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Medical Research Network
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores |
23.1; 10.57 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A) |
19.47; 10.69 | — |
| SECONDARY Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale |
28.47; 13.21 | — |
| SECONDARY Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2 |
60 | — |
| SECONDARY Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint |
4.27; 2.33 | — |
| SECONDARY Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
35.07; 48.25 | — |
| SECONDARY Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI) |
27.9; 15.0 | — |
Summary
The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.
Eligibility Criteria
Inclusion Criteria
- patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
- patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
- minimum score of 18 on the 17-item HAM-D at screen and baseline
Exclusion Criteria
- patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
- patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
- Suicidal ideation or history that makes participation in a clinical trial unduly risky
- unstable medical conditions or any abnormality in thyroid function
- patients with a QTc of 450msec or greater on the initial ECG
- patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
- the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
- patients with dementia or substance abuse in the last 6 months
- pregnant or lactating women will be excluded, as will those not using adequate forms of contraception
Data sourced from ClinicalTrials.gov (NCT00237666). 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.