Aripiprazole Treatment of the Prodrome

Prodromal Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00169949
• Other study ID #: 03-134
• Secondary ID: 03-134
• Status: Terminated
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 24, 2009
• Start date: January 2004
• Est. completion date: May 2006

Study information

• Verified date: April 2007
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 22 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prodromal Psychosis
• Prodromal Schizophrenia
• Schizotypal Personality Disorder

Intervention

Drug:
• aripiprazole

Locations

Country	Name	City	State
United States	RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on attenuated positive symptom scale at 12 weeks
Primary	Score on attenuated negative symptom scale at 12 weeks
Primary	Score on adverse events rating scale at 12 weeks
Secondary	Score on social functioning scale at 12 weeks
Secondary	Score on academic functioning scale at 12 weeks
Secondary	Score on cognitive measures at 12 weeks

External Links

•   RAP Program Homepage