A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00044044

Run by

Sumitomo Pharma America, Inc.

People needed

356

Starts

2002-07-01

Expected to finish

2003-05-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham Psychiatry Pharmaceutical — Birmingham, Alabama, United States
• Institute for Psychopharmacology Research — Cerritos, California, United States
• CNS Network — Garden Grove, California, United States
• California Clinical Trials Medical Group — Glendale, California, United States
• Optimum Health Services — La Mesa, California, United States
• University of California, Irvine — Orange, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• California Neuropsychopharmacolgoy Clinical Research Insitute — San Diego, California, United States
• Comprehensive Neuroscience. Inc. — Washington D.C., District of Columbia, United States
• Comprehensive Neuroscience. Inc. — Melbourne, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Coordinated Research of Florida, Inc. — Winter Park, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Hawaii Research Center — Honolulu, Hawaii, United States
• Alexian Brothers Behavioral Health Hospital — Hoffman Estates, Illinois, United States
• American Medical Research — Oak Brook, Illinois, United States
• Centers for Behavioral Health, LLC — Rockville, Maryland, United States
• Lake Mead Hospital — North Las Vegas, Nevada, United States
• Comprehensive Clinical Research CNS, PC — Clementon, New Jersey, United States
• ClinSearch, Inc. — Kenilworth, New Jersey, United States
• Psychiatric Professional Services Inc — Cincinnati, Ohio, United States
• Quantum Clinical Services Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.