Aripiprazole Treatment of the Prodrome

Northwell Health

Status

Terminated

Conditions

Prodromal Psychosis

Prodromal Schizophrenia

Treatments

Drug: aripiprazole

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00169949

03-134

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

13 to 22 years old

Volunteers

No 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.