Antidepressive treatment of Schizophrenia patients with agomelatine

• Conditions: Major depressive episode; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-004079-38-DE
• Lead Sponsor: Central Institute of Mental Health, Department of Psychiatry and Psychotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-27
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Contraindications against AGO treatment [compare study protocol section 1.4.5: bipolar depression, mania, suicidality (see 3.2.4), hepatic dysfunction with increased serum transminases above threefold upper limits of normal values, concomitant prescription of moderate CYP1A2 inhibitors (e.g. propranolol, grepafloxacine, enoxacine)]
2.Insufficient contraception in women of childbearing potential when sexually active. Adequate methods of contraception are: intrauterine devices (IUD), oral or depot anticontraceptives
3.Gravidity or breastfeeding.
4.Addiction to alcohol
5.Abuse of THC and other illegal substances according to ICD-10 (anamnestic data).
6.Dementia according to ICD-10.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified