Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia

Detailed description:

Arms:
arm 1: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets each morning. arm 2: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 100 mg/day armodafinil treatment arm for the double-blind treatment period of the study took two 50 mg armodafinil tablets plus two placebo tablets each morning. Subjects began taking 50 mg/day and then titrated to 100 mg/day on Day 2 of the first week of the double-blind treatment period. arm 3: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 200 mg/day armodafinil treatment arm for the double-blind treatment period of the study took four 50 mg armodafinil tablet and no placebo tablets each morning. Subjects were titrated to this dose by starting treatment at 50 mg/day (1 tablet) and increasing by 50 mg increments on days 2, 4, and 6 until they were taking 200 mg/day. arm 4: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the placebo treatment arm for the double-blind treatment period of the study took four placebo tablets and no armodafinil tablets each morning.

Interventions: intervention 1: armodafinil intervention 2: armodafinil intervention 3: armodafinil intervention 4: placebo
Intervention descriptions: intervention 1: 50 mg/day armodafinil intervention 2: 100 mg/day armodafinil intervention 3: 200 mg/day armodafinil intervention 4: placebo

Protocol document: