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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + risperidone | Placebo Comparator |
| |
| RO5545965 + risperidone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Oral daily administration from Days 1-12 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 10 weeks | |
| Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965 | 17 days | |
| Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| RO5545965 |
| Drug |
Oral daily administration from Days 1-12 |
|
| risperidone | Drug | 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. |
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