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Sponsored by: |
Max-Planck-Institute of Psychiatry |
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Information provided by: | Max-Planck-Institute of Psychiatry |
ClinicalTrials.gov Identifier: | NCT00253266 |
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
Condition | Intervention | Phase |
---|---|---|
Depression |
Drug: Venlafaxine Drug: Quetiapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression |
Estimated Enrollment: | 242 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Verum: Experimental
Quetiapine augmentation
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Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Drug: Quetiapine
Quetiapine up to 200 mg/d for four weeks
|
Placebo: Placebo Comparator
"Placebo" augmentation
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Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
|
We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas Nickel, MD | 0049 - 89 - 30622 ext 572 | nickel@mpipsykl.mpg.de |
Contact: Marcus Ising, PhD | 0049 - 89 - 30622 ext 430 | ising@mpipsykl.mpg.de |
Germany, Bavaria | |
Max-Planck-Institute of Psychiatry | Recruiting |
Munich, Bavaria, Germany, 80804 |
Principal Investigator: | Florian Holsboer, MD, PhD | Max-Planck-Institute of Psychiatry |
Responsible Party: | Max-Planck-Institute of Psychiatry ( Prof. Florian Holsboer ) |
Study ID Numbers: | 01/2005, EudraCT 2005-001217-17 |
Study First Received: | November 11, 2005 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00253266 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Treatment resistant depression Augmentation Pharmacogenetics |
Quetiapine Depression Mental Disorders Venlafaxine |
Mood Disorders Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |