Aripiprazole Treatment of the Prodrome

NCT00169949 | Terminated DMC

• 1 other identifier: 03-134
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prodromal Schizophrenia; Prodromal Psychosis

Keywords

early intervention; social functioning; role functioning; cognition

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Score on social functioning scale at 12 weeks

• Score on academic functioning scale at 12 weeks

• Score on cognitive measures at 12 weeks

Interventions

aripiprazole DRUG

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

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

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizotypal Personality Disorder; Social Adjustment

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Barbara Cornblatt, PhD

  LIJMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2004
• Study Completion: May 1, 2006
• Last Updated: September 25, 2009

Record last verified: 2007-04

Locations

US (1)