A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia.

Conditions: Adjunctive treatment of patients with sub-optimally controlled symptoms of schizophrenia. Sub-optimally controlled patients are defined as those who on their current medication have persistent symptoms of psychosis.
MedDRA version: 16.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2010-020616-11-LT

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

- Adult patients, >/= 18 years of age
- Diagnosis of schizophrenia
- Clinical stability for 16 weeks prior to randomization
- Antipsychotic treatment stability for 12 weeks prior to randomization
- With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)
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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
- Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
- Patient with body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
- Diagnosis of mental retardation or severe organic brain syndromes
- In the investigator's judgment, a significant risk of suicide or violent behavior