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CompletedNCT00224302Updated Jun 4, 2008

Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

A Phase 4 interventional study of Duloxetine in Psychotic Disorders, sponsored by Central Institute of Mental Health, Mannheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-06-04.

Sponsored by Central Institute of Mental Health, Mannheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Psychotic Disorders

Keywords

  • Schizophrenia,
  • schizoaffective disorder,
  • major depressive episode,
  • combination,
  • duloxetine
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's planned enrollment of 20 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Central Institute of Mental Health, Mannheim is the lead sponsor of 59 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • No informed consent,
  • Contraindications with respect to duloxetine,
  • Gravidity or missing anticonceptive safety
  • Substance dependance (excluded nicotin)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • DrugDuloxetine
06

What researchers measure

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

07

Study locations

1 site
  • Central Institute of Mental Health, Department of Psychiatry,
    Mannheim, BW 68159, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00224302
Lead sponsor
Central Institute of Mental Health, Mannheim
First posted
Sep 22, 2005
Start date
Aug 2005
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Jun 4, 2008

Study contacts

Mathias Zink, MD
principal investigator · Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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