Clinical Trial: Aripiprazole Treatment of the Prodrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Northwell Health

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Score on social functioning scale at 12 weeks
  • Score on academic functioning scale at 12 weeks
  • Score on cognitive measures at 12 weeks


Original Secondary Outcome: Same as current

Information By: Northwell Health

Dates:
Date Received: September 9, 2005
Date Started: January 2004
Date Completion:
Last Updated: September 24, 2009
Last Verified: April 2007