A randomised, double-blind, placebo- and olanzapine- controlled, parallel-group study to evaluate the efficacy and safety of 3 fixed doses of S 33138 in treatment of patients with an acute episode of Schizophrenia. A phase IIb, international, multicentre, 8-week study
Phase 1
- Conditions
- MedDRA version: 10.0Level: LLTClassification code 10039626Term: <Manually entered code. Term in E.1.1>Schizophrenia
- Registration Number
- EUCTR2006-006184-23-SK
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
Inpatients between 18 and 50 years of age (included), male or female, hospitalised for an acute episode of schizophrenia (relapse or recurrence).
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patient presenting a first episode of schizophrenia.
Women of childbearing potential or women who have been post menopausal for less than 2 years without effective contraception (implants, injectables, combined oral contraceptive method, intra-uterine devices, sexual abstinence or vasectomised partner) as well as pregnant or breastfeeding women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the antipsychotic efficacy of S 33138 compared to placebo;Secondary Objective: To assess the safety of S 33138, the pharmacokinetics of S 33138 and its main metabolite S 35424 and the patients’ global functioning;Primary end point(s): PANSS total score
- Secondary Outcome Measures
Name Time Method