Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4995819 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| RO4995819 15 mg | EXPERIMENTAL | - |
| RO4995819 30 mg | EXPERIMENTAL | - |
| RO4995819 5 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching placebo to RO4995819 oral once daily for 6 weeks |
| RO4995819 | DRUG | 5 mg oral once daily for 6 weeks |
Inclusion Criteria: * Adult patients, 18-65 years of age * Major depression disorder without psychotic features * Inadequate response to current, ongoing antidepressant treatment as defined by protocol * Having at least one but no more than 2 antidepressant treatment trial failures * Body mass inde...
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RO4995819 is an investigational small molecule being developed by Roche Holding AG for the treatment of major depressive disorder. It was studied in a Phase 2 clinical trial in adults who had not responded adequately to their ongoing antidepressant treatment. It is not an approved medicine.
RO4995819 was studied for major depressive disorder, specifically in patients with an inadequate response to ongoing antidepressant treatment. The research targeted this difficult-to-treat population rather than general depression. It remains an investigational agent and is not approved for any use.
Roche Holding AG is developing RO4995819. The company trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical research conducted on the compound, including the Phase 2 ARTDeCo study in major depressive disorder.
RO4995819 has completed a Phase 2 clinical trial. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Only one trial for this compound is recorded, and it is now completed with no active studies.
RO4995819 was evaluated in the Phase 2 ARTDeCo study, registered as NCT01457677. That trial enrolled 357 adults with major depressive disorder and an inadequate response to ongoing antidepressant treatment. It was randomized, double-blind, and placebo-controlled, and it has completed. Sites included the United States, Canada, Germany, Austria, Russia, Slovakia, South Africa, and Ukraine.