Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5545965 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo first; then RO5545965 15 mg; then RO5545965 5mg | PLACEBO_COMPARATOR | Participants will receive placebo matched to RO5545965 capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 5 mg capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. |
| Placebo first; then RO5545965 5 mg; then RO5545965 15 mg | PLACEBO_COMPARATOR | Participants will receive placebo matched to RO5545965 capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 5 mg capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. |
| RO5545965 15 mg first; then Placebo; then RO5545965 5 mg | EXPERIMENTAL | Participants will receive RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 1 to 3 in first intervention period; then placebo matched to RO5545965 capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 5 mg capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. |
| RO5545965 15 mg first; then RO5545965 5 mg; then Placebo | EXPERIMENTAL | Participants will receive RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 5 mg capsules orally daily from Weeks 6 to 8 in second intervention period; followed by placebo matched to RO5545965 capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. |
| RO5545965 5 mg first; then Placebo; then RO5545965 15 mg | EXPERIMENTAL | Participants will receive RO5545965 5 mg capsules orally daily from Weeks 1 to 3 in first intervention period; then placebo matched to RO5545965 capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. |
| RO5545965 5 mg first; then RO5545965 15 mg; then Placebo | EXPERIMENTAL | Participants will receive RO5545965 5 mg capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 6 to 8 in second intervention period; followed by placebo matched to RO5545965 capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. |
| Placebo + risperidone | PLACEBO_COMPARATOR | - |
| RO5545965 + risperidone | EXPERIMENTAL | - |
| RO5545965 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants will receive placebo matched to RO5545965 capsules orally daily in any of the three intervention period. |
| RO5545965 | DRUG | Participants will receive RO5545965 5 mg capsules or RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily in any of the three intervention period. |
| 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. |
Inclusion Criteria: * A diagnostic and statistical manual of mental disorders-5 (DSM-5) diagnosis of schizophrenia as established by structured clinical interview for DSM-5-clinical trial (SCID-5-CT) at screening * Participants with no hospitalization for worsening of schizophrenia within 3 months ...
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RO5545965 is an investigational small molecule being developed by Roche Holding AG for schizophrenia, a psychiatric disorder. It has been studied in Phase 1 clinical trials, including trials in participants with negative symptoms of schizophrenia and in patients receiving risperidone. It is not yet approved for any indication.
RO5545965 is being studied as a treatment for schizophrenia, including negative symptoms in patients already treated with antipsychotics. All completed trials enrolled adults with schizophrenia or healthy volunteers. It remains an investigational agent and is not approved for clinical use in schizophrenia or any other condition.
RO5545965 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche has sponsored the clinical program, which includes Phase 1 studies conducted in the United States and the United Kingdom.
RO5545965 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and no active trials are currently listed. The program has not advanced to later-stage testing, and the drug is not FDA approved.
RO5545965 has been evaluated in three completed Phase 1 trials: NCT02824055 in participants with negative symptoms of schizophrenia on antipsychotics, NCT02019329 in patients with schizophrenia on risperidone, and NCT01923025, a PET study in healthy male volunteers. Total enrollment across these trials was 74 participants.
Yes. The RO5545965 clinical program used randomized, double-blind, placebo-controlled designs. The trials enrolled adults with schizophrenia as well as healthy volunteers, and all three studies have been completed.