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Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

This study has been completed.
Sponsor:
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00224302
First received: September 15, 2005
Last updated: June 3, 2008
Last verified: September 2005
History of Changes

September 15, 2005
June 3, 2008
August 2005
November 2007   (final data collection date for primary outcome measure)
CDSS, HAMD, PANSS, SANS
Same as current
Complete list of historical versions of study NCT00224302 on ClinicalTrials.gov Archive Site
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
Same as current
Not Provided
Not Provided
 
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine

We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psychotic Disorders
Drug: Duloxetine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2007
November 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00224302
Duloxetine-Zink
Not Provided
Not Provided
Central Institute of Mental Health, Mannheim
Not Provided
Principal Investigator: Mathias Zink, MD Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
Central Institute of Mental Health, Mannheim
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP