Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
PPhase II Study on Patients With Acute Exacerbation of Schizophrena
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., December 2008
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00728195
  Purpose

Phase II study in patients with acute exacerbation of schizophrenia. The primary objective is to evaluate the 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


Condition Intervention Phase
Schizophrenia
Drug: JNJ-37822681
Phase II

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of JNJ-37822681 Administered Twice Daily in Subjects With Schizophrenia

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Estimated Enrollment: 475
Study Start Date: November 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female between 18 and 65 years of age, inclusive
  • BMI (Body Mass Index) maximum 40 kg/m2, inclusive (BMI = weight/height2)
  • Patients must have been diagnosed with schizophrenia according to DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening
  • Patients must be experiencing an acute exacerbation of less than 6 months duration, with a PANSS (Positive and Negative Syndrome Scale) total score at screening between 70 and 120 inclusive and at baseline of between 60 and 120 inclusive

Exclusion Criteria:

  • A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) axis I diagnosis other than schizophrenia
  • A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation
  • Any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
  • Relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures) or significant cerebrovascular, renal, hepatic, endocrine, or immunologic diseases
  • History of neuroleptic malignant syndrome
  • A history of diabetes or currently receiving a glucose lowering agent or treatment for diabetes
  • Patients suffering from glaucoma
  • Other significant and/or unstable systemic illnesses
  • Allergy or hypersensitivity to any known antipsychotic compounds
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728195

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

  Show 53 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Vice President )
Study ID Numbers: CR014737
Study First Received: July 31, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00728195  
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
JNJ-37822681
Central Nervous System
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 13, 2009