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Home > "A" Clinical Trials Conditions > A Comparison of Study Drug with Placebo and Haloperidol in Patients With Schizophrenia  A Comparison of Study Drug with Placebo and Haloperidol in Patients With Schizophrenia
A Comparison of Study Drug with Placebo and Haloperidol in Patients With Schizophrenia
For Condition: Schizophrenia
Status: No longer recruiting
Sponsor(s): Sumitomo Pharmaceuticals America ,
Synopsis: The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - The patient has a primary diagnosis of schizophrenia - The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening - The patient has had a duration of illness of at least one year. - The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS - The patient is able to remain off antipsychotic medication for a 4 day washout period Exclusion criteria: - The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening. - The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline - Pregnancy
Total Enrollment: 330
Location and Contact Information:
Hawaii Research Center
Honolulu, Hawaii, 96826
United States
Community Clinical Research
Austin, Texas, 78756
United States
Segal Institute for Clinical Research
Miami, Florida, 33161
United States
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, 77401
United States
Comprehensive Neuroscience. Inc.
Washington D.C., District of Columbia, 20016
United States
University Hills Clinical Research
Dallas, Texas, 75235
United States
Comprehensive Neuroscience. Inc.
Melbourne, Florida, 32935
United States
Carman Research
Smyrna, Georgia, 30080
United States
American Medical Research
Oakbrook, Illinois, 60523
United States
Affiliated Research Institute
San Diego, California, 92108
United States
Institute for Psychopharmacology Research
Cerritos, California, 90703
United States
ClinSearch, Inc.
Kenilworth, New Jersey, 07033
United States
Sharp Mesa Vista Hospital
San Diego, California, 92123
United States
CNS, Inc.
Falls Church, Virginia, 22041
United States
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850
United States
Northwest Clinical Research Center
Belleview, Washington, 98004
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
United States
FutureSearch Trials
Austin, Texas, 78756
United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, 19139
United States
Optimum Health Services
La Mesa, California, 91942
United States
Comprehensive Clinical Research CNS, PC
Clementon, New Jersey, 08021
United States
Additional Information:
Study ID Numbers: D1050049;
Study Start Date: July 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044044
Other Schizophrenia Studies:
1. Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects with Schizophrenia
2. A Comparison of Study Drug with Placebo and Haloperidol in Patients With Schizophrenia
3. Electrophysiology and Blood Flow in Patients with Schizophrenia and Their Siblings
4. Rehabilitative Training for Older People with Schizophrenia
5. Neuropsychiatric Evaluation of Healthy Volunteers and Adults with Schizophrenia
Related Studies:
Other Schizophrenia Clinical Trials
Other Virginia Clinical Trials
Other Falls Church Clinical Trials
A Comparison of Study Drug with Placebo and Haloperidol in Patients With Schizophrenia
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