Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
zonisamide · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sugar pill | EXPERIMENTAL | olanzapine and placebo ("sugar pill") |
| Zonisamide | EXPERIMENTAL | olanzapine and zonisamide (active drug) |
| Name | Type | Description |
|---|---|---|
| zonisamide | DRUG | Zonisamide will be administered at an initial dose of 100 mg/d for 7 days. Subsequently, zonisamide may be increased, based on clinical response and tolerability, by 100mg/d every 7 days to a maximum of 600 mg/d by the end of the sixth week of treatment. The maximum amount of zonisamide allowed during the study will be 600 mg/day. The minimum amount of zonisamide allowed during the study will be 100 mg/d. Zonisamide will initially be given as a single pm dose, but alterations in dosing will be permitted to reduce side effects (e.g., as BID dosing to reduce nausea). |
| olanzapine | DRUG | olanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects |
| Sugar Pill (placebo) | DRUG | sugar pill (placebo) for zonisamide |
Inclusion Criteria: Criteria for entering this study will include all of the following: 1. Subjects must be 18 years of age or older. 2. Subjects must have schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder NOS, or bipolar I, II, or NOS diso...