A phase II/III, multi-center, randomized, 4-week, double-blind, parallel group, placebo and active-controlled trial of the safety and efficacy of RO4917838 vs. placebo in patients with an acute exacerbation of schizophrenia. - Candlelyte

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

? Adult patients, 18-65 years of age
? Acute exacerbation which began within the prior 8 weeks
? Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study
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

? Current psychiatric diagnosis other than schizophrenia
alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
? Electro-convulsive therapy (ECT) within the prior 6 months
? Previous treatment with RO4917838 or another GLYT inhibitor
? Current treatment with olanzapine, or previous treatment with intolerability or lack of response
? Treatment with long-acting injectable antipsychotic within 2 dosing intervals
? Treatment with > 2 antipsychotics within 3 months
? History of neuroleptic malignant syndrome
? Have treatment resistant schizophrenia as judge by the treating physician OR have failed two trials.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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