Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 524
Healthy volunteers: no

Brief summary:
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

Detailed description:

Arms:
arm 1: Olanzapine pamoate depot arm 2: Oral olanzapine

Interventions: intervention 1: olanzapine intervention 2: olanzapine pamoate depot
Intervention descriptions: intervention 1: 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks. intervention 2: 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.

Protocol document: