Aripiprazole Treatment of the Prodrome

NCT ID: NCT00169949

Last Updated: 2009-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2006-05-31

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.

Conditions

Prodromal Schizophrenia; Prodromal Psychosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aripiprazole

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Principal Investigators

Barbara Cornblatt, PhD

Role: PRINCIPAL_INVESTIGATOR

LIJMC

Locations

RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital

Glen Oaks, New York, United States

Countries

United States

Other Identifiers

03-134

Identifier Type: -

Identifier Source: secondary_id

03-134

Identifier Type: -

Identifier Source: org_study_id