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Aripiprazole Treatment of the Prodrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00169949
Recruitment Status : Terminated (The study was terminated due to low enrollment.)
First Posted : September 15, 2005
Last Update Posted : September 25, 2009
Bristol-Myers Squibb
Information provided by:
Northwell Health

Brief Summary:
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 or disease Intervention/treatment
Prodromal Schizophrenia Prodromal Psychosis Drug: aripiprazole

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
Study Start Date : January 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

Primary Outcome Measures :
  1. Score on attenuated positive symptom scale at 12 weeks
  2. Score on attenuated negative symptom scale at 12 weeks
  3. Score on adverse events rating scale at 12 weeks

Secondary Outcome Measures :
  1. Score on social functioning scale at 12 weeks
  2. Score on academic functioning scale at 12 weeks
  3. Score on cognitive measures at 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • You are between the ages of 13 and 22.
  • You are English-speaking.
  • You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
  • OR -
  • You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
  • You meet additional RAP criteria assessed during screening and interview.

Exclusion Criteria:

  • You have a diagnosis of bipolar disorder or major depression with psychotic features.
  • You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
  • You have past or current substance dependence.
  • You are currently taking Aripiprazole.
  • You have taken Aripiprazole in the past.
  • You are currently taking and responding well to another medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169949

United States, New York
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
Bristol-Myers Squibb
Principal Investigator: Barbara Cornblatt, PhD LIJMC

Additional Information:
ClinicalTrials.gov Identifier: NCT00169949     History of Changes
Other Study ID Numbers: 03-134
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: April 2007

Keywords provided by Northwell Health:
early intervention
social functioning
role functioning

Additional relevant MeSH terms:
Schizotypal Personality Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Personality Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs