Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression|
- The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
- Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.
- Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.
- Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.
18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial.
- Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.
- Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.
- Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.
|Study Start Date:||February 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Ziprasidone monotherapy, 20-60 mg BID.
Ziprasidone 20-60 mg BID, taken orally.
Other Name: Geodon
Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:
- antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
- Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
- even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
- antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
- non-response and loss of response are common reactions to antidepressants in Bipolar II patients
This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.
This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.
Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237666
|United States, New York|
|Medical Research Network, L.L.C.|
|New York, New York, United States, 10024|
|United States, Texas|
|The Mech Center|
|Plano, Texas, United States, 75024|
|Principal Investigator:||Michael R Liebowitz, MD||Medical Research Network, L.L.C.|