Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
Primary Purpose
Psychotic Disorders
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Schizophrenia,, schizoaffective disorder,, major depressive episode,, combination,, duloxetine
Eligibility Criteria
Inclusion Criteria: Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points) Age between 18 and 65, Informed consent Exclusion Criteria: No informed consent, Contraindications with respect to duloxetine, Gravidity or missing anticonceptive safety Substance dependance (excluded nicotin)
Sites / Locations
- Central Institute of Mental Health, Department of Psychiatry,
Outcomes
Primary Outcome Measures
CDSS, HAMD, PANSS, SANS
Secondary Outcome Measures
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
Full Information
NCT ID
NCT00224302
First Posted
September 15, 2005
Last Updated
June 3, 2008
Sponsor
Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT00224302
Brief Title
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
Official Title
Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central Institute of Mental Health, Mannheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Schizophrenia,, schizoaffective disorder,, major depressive episode,, combination,, duloxetine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Primary Outcome Measure Information:
Title
CDSS, HAMD, PANSS, SANS
Secondary Outcome Measure Information:
Title
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine
Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points)
Age between 18 and 65,
Informed consent
Exclusion Criteria:
No informed consent,
Contraindications with respect to duloxetine,
Gravidity or missing anticonceptive safety
Substance dependance (excluded nicotin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Zink, MD
Organizational Affiliation
Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health, Department of Psychiatry,
City
Mannheim
State/Province
BW
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
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