Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Risperidone long-acting injectable, Risperidone Long Acting Injectable (LAI), Risperidone Long-acting Injectable
Risperidone long acting injectable · 7 trials · 4 indications
Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) \>12 or Montgomery-Åsberg Depression Rating Scale (MADRS) \>12 combined with Clinical Global Impression - Severity (CGI-S) \>=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.
Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring \<= 3 for at least 6 months
Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Risperidone Long Acting Injectable (LAI) Intramuscular injections of risperidone LAI (25 37.5 or 50 mg) every 2 weeks and oral placebo daily |
| 002 | PLACEBO_COMPARATOR | Placebo Intramuscular injections of placebo every 2 weeks and oral placebo daily |
| 003 | ACTIVE_COMPARATOR | Olanzapine Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily |
| Risperidone Long-acting Injectable (LAI) | EXPERIMENTAL | Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg. |
| Name | Type | Description |
|---|---|---|
| Olanzapine | DRUG | Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily |
| Placebo | DRUG | Intramuscular injections of placebo every 2 weeks and oral placebo daily |
| Risperidone Long Acting Injectable (LAI) | DRUG | Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily |
| Risperidone long-acting injectable | DRUG | - |
| Risperidone Long-acting Injectable (LAI) 25 mg | DRUG | Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. |
| Risperidone LAI 37.5 mg | DRUG | Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. |
| Risperidone LAI 50 mg | DRUG | Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. |
| Aripiprazole | DRUG | 10-30 mg oral once daily for 104 weeks |
| Quetiapine | DRUG | Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg. |
| Risperidone Long acting injectable | DRUG | - |
Inclusion Criteria: * Diagnosis of bipolar I disorder as defined by DSM-IV-TR criteria. All diagnoses will be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Patients who present with additional signs or symptoms compatible with Axis I diagnoses of social anxiety disorder...