Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

Phase 4

Completed

• Conditions: Psychotic Disorders

• Registration Number: NCT00224302
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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 Timeline

• Study Start: 2005-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-22
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2008-06-03
• Last Update Posted: 2008-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CDSS, HAMD, PANSS, SANS

Secondary Outcome Measures

Name	Time	Method
PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate

Trial Locations

Locations (1)

Central Institute of Mental Health, Department of Psychiatry,; 🇩🇪 Mannheim, BW, Germany