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Sponsored by: |
Technische Universität München |
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Information provided by: | Technische Universität München |
ClinicalTrials.gov Identifier: | NCT00782405 |
The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR has an immediate and lasting positive effect on sleep in depressed patients which does not differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context of a secondary objective, we expect an antidepressant effect of quetiapine XR which is equivalent to that of mirtazapine.
Condition | Intervention | Phase |
---|---|---|
Sleep |
Drug: quetiapine Drug: mirtazapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
quetiapine
|
Drug: quetiapine
XR, 150-300mg
|
2: Active Comparator
mirtazapine
|
Drug: mirtazapine
30-45 mg
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
Contact: Michael H Wiegand, Prof. | 0049894140 ext 4231 | schlafzentrum@lrz.tum.de |
Germany, Bavaria | |
Sleep Disorders Center | |
Munich, Bavaria, Germany, 81675 |
Principal Investigator: | Michael H Wiegand, Prof. | Sleep Disorders Center |
Responsible Party: | TechnischeUM ( Technical University of Munich ) |
Study ID Numbers: | D114432C00027 |
Study First Received: | October 24, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00782405 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
antidepressant action clinical psychopharmacology |
Neurotransmitter Agents Tranquilizing Agents Depression Adrenergic Agents Psychotropic Drugs Central Nervous System Depressants Adrenergic alpha-Antagonists Depressive Disorder, Major Antipsychotic Agents Depressive Disorder Mirtazapine |
Antidepressive Agents, Tricyclic Histamine Quetiapine Histamine Antagonists Mental Disorders Mood Disorders Histamine H1 Antagonists Histamine phosphate Adrenergic Antagonists Antidepressive Agents |
Neurotransmitter Agents Tranquilizing Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Histamine Agents Adrenergic alpha-Antagonists Depressive Disorder, Major Antipsychotic Agents Depressive Disorder |
Mirtazapine Pharmacologic Actions Antidepressive Agents, Tricyclic Quetiapine Histamine Antagonists Mental Disorders Therapeutic Uses Mood Disorders Histamine H1 Antagonists Adrenergic Antagonists Central Nervous System Agents Antidepressive Agents |