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Aripiprazole Treatment of Prodromal Patients

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ClinicalTrials.gov Identifier: NCT00237874
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 6, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the schizophrenia prodrome when they are prescribed aripiprazole.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychosis Drug: Aripiprazole Phase 2 Phase 3

Detailed Description:
This is an 8 week trial with extension for responders out to one year. All patients receive active medication; there is no placebo. Patients must meet criteria for the schizophrenia prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive counseling as well. All counseling and medication are free of charge.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Treatment of Prodromal Patients
Study Start Date : February 2004
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Total Score of the Scale Of Prodromal Symptoms [ Time Frame: 8 weeks ]
    This is a 19-item scale with items scores 0-6. Treatment response is defined as all 5 Scale of Prodromal Syndromes positive symtpom items being rate below the prodromal range (< or equal to 2).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 13 to 40 meet criteria for the prodrome for schizophrenia

Exclusion Criteria:

  • history of psychosis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237874


Locations
United States, Connecticut
Institute of Living
Hartford, Connecticut, United States, 06106
Yale School of Medicine
New Haven, Connecticut, United States, 06512
Sponsors and Collaborators
Yale University
Bristol-Myers Squibb
Investigators
Principal Investigator: Scott W Woods, MD Yale University
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00237874     History of Changes
Other Study ID Numbers: YaleHIC26037
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Yale University:
prodrome
ultra high risk
aripiprazole

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs