Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5545965 · 5 trials · 2 indications
| 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 | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Part 1: Placebo | PLACEBO_COMPARATOR | - |
| Part 1: RO5545965 | EXPERIMENTAL | - |
| Part 2: Food effect | 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 ...
RO5545965 is an investigational small molecule being studied in schizophrenia, including negative symptoms of schizophrenia in patients treated with antipsychotics. It has also been evaluated in healthy volunteers. The drug is in Phase 1 clinical development and is not approved by the FDA.
RO5545965 is a small molecule being developed by Roche. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its effects in schizophrenia, particularly negative symptoms, but its mechanism of action is not publicly detailed.
RO5545965 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple Phase 1 clinical trials of the drug in healthy volunteers and in patients with schizophrenia.
RO5545965 is in Phase 1 clinical development. All three completed trials of the drug were Phase 1 studies. It remains investigational and has not received FDA approval for any use.
RO5545965 has completed three Phase 1 trials. NCT01711801 studied safety and pharmacokinetics in healthy volunteers in the Netherlands. NCT01923025 was a PET study in healthy male volunteers in the United Kingdom. NCT02019329 and NCT02824055 evaluated the drug in schizophrenia patients in the United States.
RO5545965 is the only name provided for this investigational compound. No alternative names or brand names have been associated with it in the clinical trial records. It is identified solely by its code name RO5545965.