Primary Outcome Measures:
- The primary objective is to evaluate efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks' treatment in patients with schizophrenia
Secondary Outcome Measures:
- Secondary endpoints will include safety and tolerability, PANSS subscales, CGI-S, plasma markers for lipid and glucose metabolism, BMI, and body weight as well as evaluation of subjective well-being
This is a multicenter, double-blind (neither the patient nor the physician know the study medication drug name), randomized (study drug assigned by chance), placebo- and active controlled, parallel-group, dose-response study in patients with acute exacerbation of schizophrenia. Following a screening period, patients will be randomly assigned to one of five treatment groups to receive oral doses of JNJ 37822681 (10, 20 or 30 mg twice a day.) for 12 weeks, olanzapine 15 mg daily for 12 weeks, or placebo for 6 weeks followed by olanzapine 15 mg daily. for the remaining 6 weeks. Olanzapine will be initiated at 10 mg daily for 1 week and then increased to 15 mg daily for the remainder of the treatment period. Effectiveness of the primary endpoint (change in PANSS total score) will be assessed at 6 weeks. Secondary endpoints will include PANSS subscales, CGI-S, plasma markers for lipid and glucose metabolism, BMI, and body weight as well as evaluation of subjective well-being and others as detailed in Section 2. The secondary endpoints will be assessed after 6 and 12 weeks of treatment (except NOSIE after 2 weeks).
Patients will be randomly assigned to oral treatment with placebo, olanzapine (15 mg daily) or one of three dose levels of JNJ-37822681 (10, 20 or 30 mg twice a day). Patients randomized to placebo will be treated with placebo for 6 consecutive weeks and will then be treated with olanzapine, first starting on 10 mg daily for 1 week and then increasing to 15 mg daily for the remainder of their participation in the trial. Study medication will be administered orally for up to 12 consecutive weeks.