Schizophrenia |
Schizoid personality disorder; Schizotypal personality disorder |
Clinical Trial: Safety and Tolerability Study of Drug to Treat Schizophrenia
This study is no longer recruiting patients.
|
Purpose
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: SM-13496 | Phase II |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety Study
Official Title: A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 in Patients with Schizophrenia
Expected Total Enrollment: 150
Study start: September 2002; Study completion: December 2003
Eligibility
Ages Eligible for Study: 18 Years - 64 Years, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- Successful completion of participation in Sumitomo protocol #D1050049
Exclusion criteria:
- Substance abuse
- Prolactin level of ≥200ng/mL at baseline
- Pregnancy
Location Information
California
Optimum Health Services, La Mesa, California, 91942, United States
Sharp Mesa Vista Hospital, San Diego, California, 92123, United States
Institute for Psychopharmacology Research, Cerritos, California, 90703, United States
Affiliated Research Institute, San Diego, California, 92108, United States
District of Columbia
Comprehensive Neuroscience. Inc., Washington, District of Columbia, 20016, United States
Florida
Comprehensive Neuroscience. Inc., Melbourne, Florida, 32935, United States
Segal Institute for Clinical Research, North Miami, Florida, 33161, United States
Georgia
Atlanta Center for Medical Research, Atlanta, Georgia, 30308, United States
Carman Research, Smyrna, Georgia, 30080, United States
Hawaii
Hawaii Research Center, Honolulu, Hawaii, 96826, United States
Illinois
American Medical Research, Oakbrook, Illinois, 60523, United States
Maryland
Centers for Behavioral Health, LLC, Rockville, Maryland, 20850, United States
New Jersey
ClinSearch, Inc., Kenilworth, New Jersey, 07033, United States
Comprehensive Clinical Research CNS, PC, Clementon, New Jersey, 08021, United States
Pennsylvania
Quantum Clinical Services Group, Philadelphia, Pennsylvania, 19139, United States
Texas
FutureSearch Trials, Austin, Texas, 78756, United States
Community Clinical Research, Austin, Texas, 78756, United States
University Hills Clinical Research, Dallas, Texas, 75235, United States
Claghorn Lesem Research Clinic, Inc., Bellaire, Texas, 77401, United States
Virginia
CNS, Inc., Falls Church, Virginia, 22041, United States
Washington
Northwest Clinical Research Center, Belleview, Washington, 98004, United States
More Information
General information site about the acute schizophrenia trial
Record last reviewed: May 2003
Last Updated: October 13, 2004
Record first received: August 16, 2002
ClinicalTrials.gov Identifier: NCT00044005
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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