Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

• ClinicalTrials.gov Identifier: NCT00224302
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: June 4, 2008
• Sponsor: Central Institute of Mental Health, Mannheim
• Information provided by: Central Institute of Mental Health, Mannheim

Tracking Information

• First Submitted Date: September 15, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: June 4, 2008
• Study Start Date: August 2005
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 15, 2005): CDSS, HAMD, PANSS, SANS
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 15, 2005): PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
• Official Title: Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psychotic Disorders
• Intervention: Drug: Duloxetine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 15, 2005): 20
• Original Enrollment: Same as current
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00224302
• Other Study ID Numbers: Duloxetine-Zink
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Central Institute of Mental Health, Mannheim
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mathias Zink, MD; Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany

• PRS Account: Central Institute of Mental Health, Mannheim
• Verification Date: September 2005