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Sponsors and Collaborators: |
The Medical Research Network Liebowitz, Michael R., M.D. Pfizer |
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Information provided by: | The Medical Research Network |
ClinicalTrials.gov Identifier: | NCT00237666 |
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.
Condition | Intervention | Phase |
---|---|---|
Bipolar II Disorder Major Depressive Episode |
Drug: ziprasidone HCl (Geodon) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 30 |
Study Start Date: | February 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
Responsible Party: | The Medical Research Network, LLC ( Michael R. Liebowitz, M.D. ) |
Study ID Numbers: | 04-3945-A 01 |
Study First Received: | October 7, 2005 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00237666 |
Health Authority: | United States: Institutional Review Board |
Bipolar II Disorder Major Depressive Episode |
Dopamine Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Ziprasidone Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |