Agomelatine treatment of major depressive episodes in the course of schizophrenic psychoses (AGOPSYCH).A single arm, prospective pilot study - AGOPSYCH

Central Institute of Mental Health, Department of Psychiatry and Psychotherapy0 个研究点开始时间: 2012年12月27日最近更新: 2013年2月18日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Central Institute of Mental Health, Department of Psychiatry and Psychotherapy