Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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

Detailed Description

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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

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Psychotic Disorders

Keywords

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Schizophrenia, schizoaffective disorder, major depressive episode, combination, duloxetine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Duloxetine

Intervention Type DRUG

Eligibility Criteria

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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

Principal Investigators

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Mathias Zink, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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Duloxetine-Zink

Identifier Type: -

Identifier Source: org_study_id