NCT00169949

Aripiprazole Treatment of the Prodrome

Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 13 Years – 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	aripiprazole

Timeline

• Start date: 2004-01-01
• Completion: 2006-05-01
• First posted: 2005-09-15
• Last updated: 2009-09-25

Locations

1 site across 1 country: United States