Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Institute of Mental Health, Mannheim
• Collaborator: Servier
• Treatments: S 20098

Criteria

Inclusion Criteria:

1. Age between 18 and 60 years.

2. Presence of an MDE according to ICD-10 criteria (HAMD17 ≥ 18 or CDSS-Score ≥ 8 points).

3. Lifetime diagnosis of schizophrenia-spectrum disorder according to ICD-10 (F 20, F22, F23, F25).

4. Partial remission of psychotic positive symptoms (PANSS positive subscore ≤ 15 points).

5. Stable antipsychotic medication for at least 2 weeks (tolerable quantitative changes of daily dosage ≤ 25%).

6. 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 Criteria:

1. Contraindications against AGO treatment

2. Insufficient contraception in women of childbearing potential when sexually active.

3. Gravidity or breastfeeding.

4. Addiction to alcohol

5. Current abuse of THC and other illegal substances according to ICD-10

6. Dementia