Aripiprazole Treatment of the Prodrome

Sponsor

Northwell Health (Other)

Overall Status

Terminated

CT.gov ID

NCT00169949

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prodromal Schizophrenia Prodromal Psychosis	Drug: aripiprazole	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2004

Actual Study Completion Date :

May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.