Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
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ClinicalTrials.gov Identifier: NCT00224302 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : June 4, 2008
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Sponsor:
Central Institute of Mental Health, Mannheim
Information provided by:
Central Institute of Mental Health, Mannheim
Tracking Information | ||||
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First Submitted Date ICMJE | September 15, 2005 | |||
First Posted Date ICMJE | September 22, 2005 | |||
Last Update Posted Date | June 4, 2008 | |||
Study Start Date ICMJE | August 2005 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
CDSS, HAMD, PANSS, SANS | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine | |||
Official Title ICMJE | Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine | |||
Brief Summary | We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Psychotic Disorders | |||
Intervention ICMJE | Drug: Duloxetine | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
20 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00224302 | |||
Other Study ID Numbers ICMJE | Duloxetine-Zink | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Central Institute of Mental Health, Mannheim | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Central Institute of Mental Health, Mannheim | |||
Verification Date | September 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |