search
Back to results

Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R209130
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia with negative symptoms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion: Adults aged 18-60 Current diagnosis of schizophrenia Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression. Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment. Subjects must be able to provide consent Must be healthy based on medical exam, laboratory tests and electrocardiogram Exclusion: Female subjects who are either pregnant or nursing. Acute or unstable medical conditions Diseases of the central nervous system Subjects who are judged clinically to be at serious risk for suicide or violence Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.
  • IPR
  • Synergy Clinical Research
  • Optimum Health Services
  • Sierra Vista Hospital
  • Clinical Innovations
  • Research Strategies
  • University of Colorado
  • Psychiatric Institute of Washington
  • Berma Research Group
  • Segal Institute for Clinical Research
  • Quantum Laboratories
  • Med Psych Specialists, LLC
  • Alexian Brothers Behavioral Health Hospital
  • Midwest Center for Neurobehavioral Medicine
  • University of Mississippi Medical Center-Dept. of Psychiatry
  • CNS Research Institute
  • Neurobehavioral Research
  • Global Research & Consulting
  • Bayley Seton Campus-Psychiatric Research Division
  • Behavioral Medical Research of Staten Island, P.C.
  • NorthCoast Clinical Trials
  • IPS Research
  • Vanderbilt University Medical Center
  • Community Clinical Research
  • MedLabs Research of Houston
  • University Hills Clinical Research
  • Milwaukee VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 25, 2003
Last Updated
August 27, 2009
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
search

1. Study Identification

Unique Protocol Identification Number
NCT00063297
Brief Title
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

5. Study Description

Brief Summary
This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia with negative symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
R209130

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Adults aged 18-60 Current diagnosis of schizophrenia Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression. Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment. Subjects must be able to provide consent Must be healthy based on medical exam, laboratory tests and electrocardiogram Exclusion: Female subjects who are either pregnant or nursing. Acute or unstable medical conditions Diseases of the central nervous system Subjects who are judged clinically to be at serious risk for suicide or violence Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical Studies, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
IPR
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Synergy Clinical Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Optimum Health Services
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sierra Vista Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Clinical Innovations
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Research Strategies
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Psychiatric Institute of Washington
City
Washington, DC
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Quantum Laboratories
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Med Psych Specialists, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30340
Country
United States
Facility Name
Alexian Brothers Behavioral Health Hospital
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Midwest Center for Neurobehavioral Medicine
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
University of Mississippi Medical Center-Dept. of Psychiatry
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
14760
Country
United States
Facility Name
Neurobehavioral Research
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
Global Research & Consulting
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
Bayley Seton Campus-Psychiatric Research Division
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
Behavioral Medical Research of Staten Island, P.C.
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
NorthCoast Clinical Trials
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
MedLabs Research of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Milwaukee VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia

We'll reach out to this number within 24 hrs