Schizophrenia
Conditions
Brief summary
This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.
Interventions
10 mg orally daily, 4 weeks
DRUGolanzapine
15 mg orally daily, 4 weeks
DRUGplacebo
orally daily, 4 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, 18-65 years of age * Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR) * 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
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 judged by treating physician or have failed two trials according to criteria in protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) total score | from baseline to Day 28 |
| Safety: Incidence adverse events | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale | from baseline to Day 28 |
| Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale | from baseline to Day 28 |
| Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score | from baseline to Day 28 |
| Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ) | from baseline to Day 28 |
| Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE) | from baseline to Day 28 |
| Change in symptomatology as measured by the PANSS factor and subscale scores | from baseline to Day 28 |
Countries
Romania, Russia, Slovakia, Ukraine, United States
Outcome results
None listed