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

NCT00728195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2014-03-26

No results posted yet for this study

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).

Conditions

Interventions

DRUG

JNJ-37822681

Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks.

DRUG

JNJ-37822681

Participants will receive JNJ-37822681 capsule 20 mg orally twice a day for 12 consecutive weeks.

DRUG

JNJ-37822681

Participants will receive JNJ-37822681 capsule 30 mg orally twice a day for 12 consecutive weeks.

DRUG

Olanzapine

Participants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks.

DRUG

Placebo

Participants will receive matching placebo capsules orally for 12 weeks.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Bulgaria
  • Estonia
  • Lithuania
  • Malaysia
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00728195 on ClinicalTrials.gov