An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
  
  

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: No ]
  The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). Positive subscale score ranges from 7 (absent) to 49 (extreme psychopathology), negative subscale score ranges from 7 (absent) to 49 (extreme psychopathology) and general psychopathology subscale score ranges from 16 (absent) to 112 (extreme psychopathology).
  
  
• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: No ]
  The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49 and uncontrolled hostility/excitement (UHE) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity.
  
  
• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: No ]
  The CGI-S rating scale assesses the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
  
  
• Change From Baseline in Subjective Well-Being on Neuroleptics (SWN) Total Score at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: No ]
  The SWN is a participant self rated scale to evaluate the participant's feelings during the past 7 days on a form with 20 statements, subsequently divided into 5 subscales: mental-functioning, self-control, emotional regulation, physical functioning and social integration. Each item is scored between 1 (not at all) and 6 (very much). Total score ranges from 20-120 with higher scores indicating higher subjective well-being.
  
  
• Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE) Total Score at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  The NOSIE comprises 30 items which form 6 scales: social competence, social interest, personal neatness, irritability, manifest psychosis and retardation and is completed by a suitably trained and experienced member of the nursing staff. Each item is scored from 0 (never) to 4 (always). It was assessed only at 2 weeks when the participants were hospitalized. Total score ranges from 0 to 120, with lower score indicating better results.
  
  
• Change From Baseline in Plasma Markers Level for Lipid and Glucose Metabolism at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: Yes ]
  Change from baseline in the level of plasma (liquid part of blood where cells float) markers for lipid (fat) and glucose (type of sugar found in the blood) metabolism (process of breaking down substances in the cells to obtain energy) is calculated. Markers for lipid metabolism include fasting total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), triglycerides and free fatty acids. Fasting glucose level is used as marker for glucose metabolism.
  
  
• Change From Baseline in Free Fatty Acids Level at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: Yes ]
  Change from baseline in the level of free fatty acids (plasma marker for lipid metabolism) is calculated.
  
  
• Change From Baseline in Insulin Level at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: Yes ]
  Change from baseline in the level of insulin (the hormone that controls blood sugar levels) as plasma marker for glucose metabolism is calculated.
  
  
• Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: Yes ]
  Change from baseline in the level of glycosylated hemoglobin (substance that carries oxygen and gives blood its red color) as plasma marker for glucose metabolism is calculated.
  
  
• Change From Baseline in Body Mass Index (BMI) at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: Yes ]
  The BMI is calculated by dividing the weight (in kilogram) by square of height (in meters).
  
  
• Change From Baseline in Body Weight at Week 6 and 12 [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: Yes ]
  

This is a multicenter (when more than one hospital or medical school team work on a medical research study), double-blind (neither the participant nor the physician know the study medication drug name), randomized (study drug assigned by chance), placebo- and active-controlled, parallel-group (a clinical trial comparing the response in two or more groups of participants receiving different treatments), dose-response study in participants with schizophrenia. The total study duration will not exceed 16 weeks for each participant and will include following visits: screening, baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 11 and 13 (end of treatment or early withdrawal), and a post-study safety visit (1 week after final dose of study drug). All participants will be hospitalized during the first 2 weeks of treatment for detailed follow-up of safety and disease status. Following a screening period, participants will be randomly assigned to one of 5 treatment groups to receive oral doses of JNJ-37822681 (10, 20 or 30 milligram [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. Efficacy will primarily be evaluated by Positive And Negative Syndrome Scale (PANSS). Participants' safety will also be monitored at each visit.