Status:
COMPLETED
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborating Sponsors:
Servier
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 agomel...
Detailed Description
Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomel...
Eligibility Criteria
Inclusion
- Age between 18 and 60 years.
- Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).
- Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).
- Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).
- Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).
- The patient is able to give an informed consent. In case of legal guardianship, the custodian will have to agree to the patient's participation.
Exclusion
- Contraindications against AGO treatment
- Insufficient contraception in women of childbearing potential when sexually active.
- Gravidity or breastfeeding.
- Addiction to alcohol
- Current abuse of THC and other illegal substances according to ICD-10
- Dementia
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01822418
Start Date
January 1 2013
End Date
December 1 2015
Last Update
March 8 2018
Active Locations (1)
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1
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, Germany, 68159