Clinical trial NCT00063297: Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia with negative symptoms
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2003-06-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Cerritos
country: United States
facility: IPR
state: California
city: Chula Vista
country: United States
facility: Synergy Clinical Research
state: California
city: La Mesa
country: United States
facility: Optimum Health Services
state: California
city: Sacramento
country: United States
facility: Sierra Vista Hospital
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations
state: California
city: Torrance
country: United States
facility: Research Strategies
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Washington, DC
country: United States
facility: Psychiatric Institute of Washington
state: District of Columbia
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Atlanta
country: United States
facility: Med Psych Specialists, LLC
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobehavioral Medicine
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center-Dept. of Psychiatry
state: Mississippi
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Lawrence
country: United States
facility: Neurobehavioral Research
state: New York
city: Olean
country: United States
facility: Global Research & Consulting
state: New York
city: Staten Island
country: United States
facility: Bayley Seton Campus-Psychiatric Research Division
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island, P.C.
state: New York
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Houston
country: United States
facility: MedLabs Research of Houston
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Milwaukee
country: United States
facility: Milwaukee VA Medical Center
state: Wisconsin
Study officials:
References: