Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the safety, tolerability, and potential clinical
      efficacy of JNJ 40411813 in schizophrenic patients.
    

Detailed description: 
      This is a first-in-human study of JNJ-40411813 in schizophrenic patients who are not
      currently receiving antipsychotic drug treatment (referred to as "(sub) acute" patients) and
      in patients who are currently taking antipsychotic drug treatment (referred to as "stable"
      patients). The study will consist of 2 parts: Part A and Part B. Part A will be open-label
      (patients will know the identity of study treatment), and (sub)acute schizophrenic patients
      will receive monotherapy (treatment with one drug) with JNJ-40411813. Part B will be
      double-blind (patient and study staff will not know the identity of study treatment) and will
      randomize (assign by chance) patients with stable but symptomatic schizophrenia to receive
      treatment with JNJ-40411813 or a placebo (treatment identical in appearance to JNJ-40411813
      but does not contain active drug) as add-on therapy to their currently prescribed
      antipsychotic medication. Parts A (JNJ-40411813 monotherapy) and B (JNJ-40411813 add-on
      therapy) will run simultaneously. Patients will take JNJ-40411813 and placebo capsules orally
      (by mouth) twice daily (bid) with a meal. Part A: Patients will take JNJ-40411813 50 mg (1
      capsule) bid up to 150 mg (3 capsules) bid for up to 12 weeks. Part B: Patients will take
      JNJ-40411813 50 mg bid or placebo bid for 4 weeks. After 4 weeks, the dose of JNJ-40411813
      may be increased up to 150 mg bid for 6 weeks, and patients assigned to placebo may take
      JNJ-40411813 50 mg bid to 150 mg bid for up to 10 weeks.
    

Intervention name(s): JNJ-40411813; JNJ-40411813; Placebo; Antipsychotic medication
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks.; JNJ-40411813 starting dose from 50 to 150 mg as an add-on therapy. Dose is increased step-wise from 50 mg to 150 mg. Capsule(s) taken by mouth twice daily with a meal for 10 weeks.; Placebo capsule (s) orally twice daily with a meal for 4 weeks.; Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B.
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JNJ-40411813