Aripiprazole Treatment of the Prodrome

This study has been terminated.
(The study was terminated due to low enrollment.)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00169949
First received: September 9, 2005
Last updated: September 24, 2009
Last verified: April 2007
  Purpose

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
Prodromal Schizophrenia
Prodromal Psychosis
Drug: aripiprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Score on attenuated positive symptom scale at 12 weeks
  • Score on attenuated negative symptom scale at 12 weeks
  • Score on adverse events rating scale at 12 weeks

Secondary Outcome Measures:
  • Score on social functioning scale at 12 weeks
  • Score on academic functioning scale at 12 weeks
  • Score on cognitive measures at 12 weeks

Estimated Enrollment: 30
Study Start Date: January 2004
Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   13 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169949

Locations
United States, New York
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Bristol-Myers Squibb
Investigators
Principal Investigator: Barbara Cornblatt, PhD LIJMC
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00169949     History of Changes
Other Study ID Numbers: 03-134, 03-134
Study First Received: September 9, 2005
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:
early intervention
social functioning
role functioning
cognition

Additional relevant MeSH terms:
Schizotypal Personality Disorder
Mental Disorders
Psychotic Disorders
Schizophrenia
Personality Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014