Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

Psychotic Disorders Clinical Trial

Official title:

Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224302
• Other study ID #: Duloxetine-Zink
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: June 3, 2008
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: September 2005
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Duloxetine

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health, Department of Psychiatry,	Mannheim	BW

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDSS, HAMD, PANSS, SANS
Secondary	PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate