An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of 3 fixed doses of
      JNJ-37822681 compared with placebo (an inactive substance that is compared with a drug to
      test if the drug has a real effect in a clinical trial) after 6 weeks treatment and
      olanzapine after 12 weeks treatment in participants with schizophrenia (psychiatric disorder
      with symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self).
    

Detailed description: 
      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.
    

Intervention name(s): JNJ-37822681; JNJ-37822681; JNJ-37822681; Olanzapine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks.; Participants will receive JNJ-37822681 capsule 20 mg orally twice a day for 12 consecutive weeks.; Participants will receive JNJ-37822681 capsule 30 mg orally twice a day for 12 consecutive weeks.; Participants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks.; Participants will receive matching placebo capsules orally for 12 weeks.
Intervention MeSH terms: Olanzapine; N-(1-(3,4-difluorobenzyl)piperidin-4-yl)-6-(trifluoromethyl)pyridazin-3-amine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Central Nervous System; JNJ-37822681