Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)

NCT01822418 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-03-08

No results posted yet for this study

Summary

Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.

Conditions

Interventions

DRUG

agomelatine

Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY
  • Central Institute of Mental Health, Mannheim

    lead OTHER

Principal Investigators

  • Mathias Zink, MD · Central Institute of Mental Health, Department of Psychiatry and Psychotherapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822418 on ClinicalTrials.gov