Back to resultsAripiprazole Treatment of the Prodrome
Primary Purpose
Prodromal Schizophrenia, Prodromal Psychosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Prodromal Schizophrenia focused on measuring early intervention, social functioning, role functioning, cognition
Eligibility 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.
Sites / Locations
- RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Outcomes
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
Full Information
NCT ID
NCT00169949
First Posted
September 9, 2005
Last Updated
September 24, 2009
Sponsor
Northwell Health
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00169949
Brief Title
Aripiprazole Treatment of the Prodrome
Official Title
Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to low enrollment.
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northwell Health
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prodromal Schizophrenia, Prodromal Psychosis
Keywords
early intervention, social functioning, role functioning, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Primary Outcome Measure Information:
Title
Score on attenuated positive symptom scale at 12 weeks
Title
Score on attenuated negative symptom scale at 12 weeks
Title
Score on adverse events rating scale at 12 weeks
Secondary Outcome Measure Information:
Title
Score on social functioning scale at 12 weeks
Title
Score on academic functioning scale at 12 weeks
Title
Score on cognitive measures at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Cornblatt, PhD
Organizational Affiliation
LIJMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.rapprogram.org/
Description
RAP Program Homepage
Learn more about this trial
Aripiprazole Treatment of the Prodrome
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