Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT00237666
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2005-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Sponsor:
The Medical Research Network
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: