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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Lurasidone 20 mg (Drug); Lurasidone 40mg (Drug); Lurasidone 80 mg (Drug); Haloperidol 10mg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sunovion

Official(s) and/or principal investigator(s):
Medical Director, MD, Study Director, Affiliation: Sunovion

Summary

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.

Clinical Details

Official title: A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score

Secondary outcome:

Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores

Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores

Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

Birmingham Psychiatry Pharmaceutical, Birmingham, Alabama 35209, United States

Institute for Psychopharmacology Research, Cerritos, California 90703, United States

CNS Network, Garden Grove, California 92845, United States

California Clinical Trials Medical Group, Glendale, California 91206, United States

Optimum Health Services, La Mesa, California 91942, United States

University of California, Irvine, Orange, California 92868, United States

Affiliated Research Institute, San Diego, California 92108, United States

California Neuropsychopharmacolgoy Clinical Research Insitute, San Diego, California 92126, United States

Sharp Mesa Vista Hospital, San Diego, California 92123, United States

Comprehensive Neuroscience. Inc., Washington, District of Columbia 20016, United States

Comprehensive Neuroscience. Inc., Melbourne, Florida 32935, United States

Segal Institute for Clinical Research, North Miami, Florida 33161, United States

University of South Florida, Tampa, Florida 33613, United States

Coordinated Research of Florida, Inc., Winter Park, Florida 32789, United States

Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States

Carman Research, Smyrna, Georgia 30080, United States

Hawaii Research Center, Honolulu, Hawaii 96826, United States

Alexian Brothers Behavioral Health Hospital, Hoffman Estates, Illinois 60194, United States

American Medical Research, Oakbrook, Illinois 60523, United States

Centers for Behavioral Health, LLC, Rockville, Maryland 20850, United States

Lake Mead Hospital, North Las Vegas, Nevada 89030, United States

Comprehensive Clinical Research CNS, PC, Clementon, New Jersey 08021, United States

ClinSearch, Inc., Kenilworth, New Jersey 07033, United States

Psychiatric Professional Services Inc, Cincinnati, Ohio 45267, United States

Albert Einstein Medical Center - Dept. of Psychiatry, Philadelphia, Pennsylvania 19141, United States

Quantum Clinical Services Group, Philadelphia, Pennsylvania 19139, United States

Community Clinical Research, Austin, Texas 78756, United States

FutureSearch Trials, Austin, Texas 78756, United States

Claghorn Lesem Research Clinic, Inc., Bellaire, Texas 77401, United States

St. Paul Medical Center, Dallas, Texas 75235, United States

University Hills Clinical Research, Dallas, Texas 75235, United States

CNS, Inc., Falls Church, Virginia 22041, United States

Northwest Clinical Research Center, Belleview, Washington 98004, United States

Medstream, Inc., Milwaukee, Wisconsin 53210, United States

Additional Information

Starting date: July 2002
Last updated: March 31, 2014

Page last updated: August 23, 2015

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