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Completed

NCT Number: NCT00224302

Treatment of MDEs 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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, 68159, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Duloxetine

Drug

Primary outcomes

  1. CDSS, HAMD, PANSS, SANS

Secondary outcomes

  1. PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Jun 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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