Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

Central Institute of Mental Health, Mannheim

Status and phase: Completed; Phase 4

Conditions: Psychotic Disorders

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00224302

Duloxetine-Zink

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)