A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Schizophrenia
Interventions
OTHER

Placebo

Oral daily administration from Days 1-12

DRUG

RO5545965

Oral daily administration from Days 1-12

DRUG

risperidone

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.

Trial Locations (1)

91206

Glendale

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02019329 - A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone | Biotech Hunter | Biotech Hunter