This randomized, double-blinded, placebo-controlled study will investigate the safety, tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to psychiatrically stable patients with schizophrenia receiving risperidone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Oral daily administration from Days 1-12
Oral daily administration from Days 1-12
13 day run-in phase until 4 mg daily dose level is reached. 4 mg daily oral dose until Day 17 of study, for a total of 30 days. Dose may be increased up to 6 mg at the investigator's discretion. After study treatment, risperidone dosage may be decreased, increased or omitted at the investigator's discretion during a wash-out phase while patients return to their chronic antipsychotic treatment. Patient response during wash-out will be monitored in-house for 48 hours after the last dose of RO5545965 or placebo is administered. This in-house observation may be extended as needed by the investigator.
Unnamed facility
Glendale, California, United States
Incidence of adverse events
Time frame: Up to 10 weeks
Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs.
Time frame: Up to 10 weeks
Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965
Time frame: 17 days
Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone
Time frame: 15 days
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