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Sponsors and Collaborators: |
North Shore Long Island Jewish Health System Bristol-Myers Squibb |
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Information provided by: | North Shore Long Island Jewish Health System |
ClinicalTrials.gov Identifier: | NCT00169949 |
The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.
Condition | Intervention |
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Prodromal Schizophrenia Prodromal Psychosis |
Drug: aripiprazole |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness |
Estimated Enrollment: | 30 |
Study Start Date: | January 2004 |
Study Completion Date: | May 2006 |
During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.
Ages Eligible for Study: | 13 Years to 22 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital | |
Glen Oaks, New York, United States, 11004 |
Principal Investigator: | Barbara Cornblatt, PhD | LIJMC |
Study ID Numbers: | 03-134, 03-134 |
Study First Received: | September 9, 2005 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00169949 |
Health Authority: | United States: Food and Drug Administration |
early intervention social functioning role functioning cognition |
Schizophrenia Mental Disorders Schizotypal Personality Disorder Psychotic Disorders |
Aripiprazole Schizophrenia and Disorders with Psychotic Features Personality Disorders |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |