Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
amantadine · 1 trial · 2 indications
| 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...
Amantadine is an investigational small molecule being studied for use in schizophrenia and schizoaffective disorders. In clinical development, it is being evaluated for the prevention of weight gain associated with olanzapine treatment in patients with these conditions. It is not approved for this use and remains in clinical trials.
Amantadine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to assess the drug's safety and efficacy in the context of schizophrenia and schizoaffective disorders.
Amantadine is in Phase 3 clinical development for use in schizophrenia and schizoaffective disorders. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed, with a total enrollment of 199 participants.
Amantadine has one completed Phase 3 clinical trial registered under NCT00401973, titled 'Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine.' The trial enrolled 199 participants across the United States, Brazil, Israel, Mexico, Puerto Rico, Russia, and South Korea.
Amantadine is not FDA approved for the prevention of weight gain associated with olanzapine in schizophrenia or schizoaffective disorders. It is an investigational drug currently in clinical development, with a completed Phase 3 trial. Approval status beyond this specific indication is not part of the available information.