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Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00224302
Enrollment
20
Registered
2005-09-22
Start date
2005-08-31
Completion date
2007-11-30
Last updated
2008-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders

Keywords

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

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.

Interventions

DRUGDuloxetine

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

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

Design outcomes

Primary

MeasureTime frame
CDSS, HAMD, PANSS, SANS

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026