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Sponsors and Collaborators: |
Duke University Pfizer National Institute of Mental Health and Neuro Sciences, India |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00340379 |
The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.
Condition | Intervention | Phase |
---|---|---|
Affective Disorders |
Drug: Ziprasidone Drug: Sertraline Drug: Haloperidol |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol |
Estimated Enrollment: | 75 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | August 2005 |
Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of Southern California | |
Los Angeles, California, United States, 90033 | |
Egypt | |
Alexandria University | |
Alexandria, Egypt | |
India | |
National Institute of Mental Health and Neuroscience | |
Bangalore, India, 560029 |
Principal Investigator: | Frederick Cassidy, MD | Duke University |
Principal Investigator: | George Simpson, MD | University of Southern California |
Principal Investigator: | Ranga Krishnan, MD | Duke University |
Principal Investigator: | Sumant Khanna, MD | National Institute of Mental Health and Neuroscience |
Principal Investigator: | Adel Elsheshai, MD | Alexandria University |
Study ID Numbers: | 3846-05-6R2 |
Study First Received: | June 20, 2006 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00340379 |
Health Authority: | United States: Institutional Review Board; Egypt: Ethics Committee; India: Ethics Committee |
Psychotic |
Depression Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms Haloperidol Haloperidol decanoate |
Dopamine Mental Disorders Mood Disorders Sertraline Psychotic Disorders Ziprasidone |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Antidepressive Agents |