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Also known as Bitopertin
RO4917838 · 10 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| RO4917838 20 milligrams (mg) | EXPERIMENTAL | Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years. |
| RO4917838 10 mg | EXPERIMENTAL | Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years. |
| Placebo | PLACEBO_COMPARATOR | Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks. |
| Bitopertin oral dose level 1 | EXPERIMENTAL | - |
| Bitopertin oral dose level 2 | EXPERIMENTAL | - |
| Bitopertin 10 mg + Antipsychotics | EXPERIMENTAL | Treatment Period 1: Participants will receive bitopertin 10 milligrams (mg) tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 10 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50 percent (%) of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study. |
| Bitopertin 20 mg + Antipsychotics | EXPERIMENTAL | Treatment Period 1: Participants will receive bitopertin 20 mg tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 20 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50% of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 20 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study. |
| Bitopertin | EXPERIMENTAL | Part 1 - The main study - 16 weeks in total: Participants will undergo a 6-week dose-escalation period followed by 10 weeks of treatment at the attained target dose of bitopertin. Part 2 - Open Label Extension (OLE) - up to an additional 12 months: Participants will be given the option to enroll into the OLE once the 16-week treatment of Part 1 has been completed. Participants who decide not to enroll in the OLE, at the end of Part 1 will enter a 6-week follow-up period. |
| Bitopertin 30 mg | EXPERIMENTAL | Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. |
| Bitopertin 10 mg | EXPERIMENTAL | Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| D | PLACEBO_COMPARATOR | - |
| 4 | PLACEBO_COMPARATOR | - |
| RO4917838 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral doses, once a day for 52 weeks |
| RO4917838 | DRUG | Oral dose level 1, once a day for 52 weeks |
| Antipshychotics (Standard of Care) | DRUG | Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56. |
| bitopertin [RO4917838] | DRUG | Oral dose level 1, once a day for 52 weeks |
| Bitopertin | DRUG | Participants will receive 10 mg or 20 mg of bitopertin. |
| Antipsychotics | DRUG | Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen. |
| SSRI | DRUG | Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen. |
| olanzapine | DRUG | 15 mg orally daily, 4 weeks |
| Standard antipsychotic therapy | DRUG | As prescribed |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Diagnosis of schizophrenia * Clinical stability for 16 weeks (4 months) prior to randomization * Antipsychotic treatment stability for the past 12 weeks prior to randomization * With the exception of clozapine, patients are on any of the ...
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RO4917838 is an investigational small molecule developed by Roche Holding AG for the treatment of schizophrenia. It has been studied in four completed clinical trials, including two Phase 3 studies, and is not approved for any indication. The drug was evaluated as an adjunct to antipsychotic treatment and for persistent negative symptoms.
RO4917838 was studied for schizophrenia, including sub-optimally controlled symptoms and persistent, predominant negative symptoms. It was also tested for cognitive dysfunction in schizophrenia and schizoaffective disorder. All trials are completed, and the drug remains investigational.
RO4917838 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical development program for the drug in schizophrenia.
RO4917838 has completed Phase 3 clinical trials. The program includes two Phase 3 studies, one Phase 2 study, and one Phase 1 study, all listed as completed. There are no active trials, and the drug is not approved for any indication.
RO4917838 has been studied in four completed trials: NCT01235520 (Phase 3, 595 participants), NCT01192867 (Phase 3, 629 participants), NCT01116830 (Phase 1, 29 participants), and NCT00616798 (Phase 2, 323 participants). All enrolled adults with schizophrenia or schizoaffective disorder.
No, RO4917838 is not the same as rosuvastatin. RO4917838 is an investigational small molecule developed by Roche for schizophrenia, while rosuvastatin is a marketed statin used for cholesterol management. The names are sometimes confused, but they refer to different drugs.