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Open label trial exploring a switch from oral medications, to risperidone depot microspheres - Article


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Haloperidol Tablets

Haldol Tablets



Clinical Trial: Open label trial exploring a switch from oral medications, to risperidone depot microspheres

This study has been completed.

Sponsored by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

The purpose of this trial is to look at the effectiveness of patients being switched from haldol, seroquel or zyprexa to biweekly risperidone injections.

Condition Treatment or Intervention Phase
Schizophrenia
 Drug: risperidone, quetiapine, olanzapine, haloperidol
Phase III

MedlinePlus related topics:  Schizophrenia

Study Type: Interventional
Study Design: Treatment

Official Title: Open label trial exploring a switching regimen from oral neuroleptics, other than risperidone, to risperidone depot microspheres

Further Study Details: 

Expected Total Enrollment:  141

Study start: July 2001;  Study completion: October 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Diagnosis of schizophrenia according to the DSM IV criteria (295.10, 295.20, 295.30, 295.60, 295.90);
  • Currently treated with either oral haloperidol, quetiapine fumarate, or olanzapine for 4 months prior to trial entry;
  • PANSS score of <80; on each of the following PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content, the score is < 4;
  • Subject with a body mass index < 35 at screening

Location Information


Arkansas
      Clinical Studies Center, Little Rock,  Arkansas,  72205,  United States

California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States

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

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

      Comprehensive NeuroScience-IPR, Cerritos,  California,  90703,  United States

      BMR HealthQuest, Glendale,  California,  91206,  United States

District of Columbia
      Comprehensive NeuroScience, Inc, Washington,  District of Columbia,  20016,  United States

Florida
      ICSL - Clinical Studies, Melbourne,  Florida,  32935,  United States

      Berma Research Group, Hialeah,  Florida,  33016,  United States

Georgia
      Carman Research, Smyrna,  Georgia,  30080,  United States

Hawaii
      Hawaii Clinical Research Center, Honolulu,  Hawaii,  96826,  United States

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

Louisiana
      LSU Behavioral Research Institute, New Orleans,  Louisiana,  70112,  United States

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

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

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

New York
      Neurobehavior Research Inc., Lawrence,  New York,  11559,  United States

      Neuropsych Research Associates, New York,  New York,  10128,  United States

      Manhattan Psychiatric Center, New York,  New York,  10035,  United States

      Behavioral Medical Research, Staten Island,  New York,  10305,  United States

Oklahoma
      IPS Research, Oklahoma City,  Oklahoma,  73103,  United States

Pennsylvania
      VA Medical Center, Coatesville,  Pennsylvania,  19320-2096,  United States

South Carolina
      South Carolina VA Medical Center, Charleston,  South Carolina,  29401-5799,  United States

Tennessee
      Clinical Research Services @Tennessee Christian Medical Center, Madison,  Tennessee,  37115,  United States

Texas
      Community Clinical Research, Inc, Austin,  Texas,  78756,  United States

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

      Med Labs Research of Houston, Inc., Houston,  Texas,  77057,  United States

      Univ. of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States

Virginia
      Medical College of Virginia, Richmond,  Virginia,  23298,  United States

More Information

Study ID Numbers:  RIS-USA-259
Record last reviewed:  January 2003
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034775
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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November 18, 2008



Page Updated: June 1, 2005
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