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| Sponsored by: |
Central Institute of Mental Health, Mannheim |
|---|---|
| Information provided by: | Central Institute of Mental Health, Mannheim |
| ClinicalTrials.gov Identifier: | NCT00224302 |
Purpose
We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders
| Condition | Intervention | Phase |
|---|---|---|
|
Psychotic Disorders |
Drug: Duloxetine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2005 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Major depressive episodes (MDE) frequently occur during the course of schizophrenic psychoses, both as as "post-psychotic" depressions, and also independently from psychotic episodes. A number of clinical studies reported the application of different antidepressive substances, such as Imipramine, Reboxetine or Venlafaxine. In general, the treatment of schizophrenic patients with antidepressive drugs can be considered as necessary and save, resulting in therapeutic guidelines of different psychiatric societies. However, since 5 to 10 % of the schizophrenic patients commit suicide, there is still much effort necessary in order to improve the treatment of affective symptoms in schizophrenic psychoses.The recently introduced antidepressive substance Duloxetine selectively inhibits as a SSNRI the reuptake of serotonine and noradrenaline from the synaptic cleft. Duloxetine was proven as antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled investigations. Based on these considerations and on successful experiences in single case reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime diagnoses of the schizophrenic spectrum.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany, BW | |
| Central Institute of Mental Health, Department of Psychiatry, | |
| Mannheim, BW, Germany, 68159 | |
| Principal Investigator: | Mathias Zink, MD | Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany |
More Information
| Study ID Numbers: | Duloxetine-Zink |
| Study First Received: | September 15, 2005 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00224302 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Schizophrenia, schizoaffective disorder, major depressive episode, combination, duloxetine |
|
Schizophrenia Dopamine Depression Mental Disorders |
Psychotic Disorders Serotonin Duloxetine Schizophrenia and Disorders with Psychotic Features |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Uptake Inhibitors Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |
