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

Phase 1

• 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.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2010-020696-23-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-19
• Study Completion: 2014-07-08
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 588

Inclusion Criteria

- Adult patients, >/= 18 years of age
- Diagnosis of schizophrenia
- Clinical stability for the 16 weeks (4 months) prior to randomisation
- Antipsychotic treatment stability for 12 weeks prior to randomisation
- 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) <18.5 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

Study & Design

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