Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

NCT ID: NCT00224302

Last Updated: 2008-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-11-30

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.

Conditions

Psychotic Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Duloxetine

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Principal Investigators

Mathias Zink, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany

Locations

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

Duloxetine-Zink

Identifier Type: -

Identifier Source: org_study_id