Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00401973 | Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine | PHASE3 | COMPLETED | 199 | — | — | Nov 1, 2006 | Sep 1, 2008 | Oct 6, 2009 | 15 | United States, Brazil +5 |
| Arm | Type | Description |
|---|---|---|
| Olanzapine | EXPERIMENTAL | olanzapine plus behavioral information |
| Olanzapine + Amantadine | EXPERIMENTAL | Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information |
| Olanzapine + Metformin | EXPERIMENTAL | Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information |
| Name | Type | Description |
|---|---|---|
| olanzapine | DRUG | 5-20 milligrams (mg), oral, daily for 22 weeks. |
| amantadine | DRUG | Amantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide. |
| metformin | DRUG | Metformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide. |
| zonisamide | DRUG | Zonisamide, 100-400mg, oral, daily. |
| Wellness education | BEHAVIORAL | weight management |
Inclusion Criteria: * You must have been diagnosed with schizophrenia or schizoaffective disorder * You must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month * If y...