Aripiprazole Treatment of the Prodrome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prodromal Schizophrenia Prodromal Psychosis |
Drug: aripiprazole |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness |
- 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
- Score on social functioning scale at 12 weeks
- Score on academic functioning scale at 12 weeks
- Score on cognitive measures at 12 weeks
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2004 |
| Study Completion Date: | May 2006 |
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.
Eligibility| Ages Eligible for Study: | 13 Years to 22 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, New York | |
| RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital | |
| Glen Oaks, New York, United States, 11004 | |
| Principal Investigator: | Barbara Cornblatt, PhD | LIJMC |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00169949 History of Changes |
| Other Study ID Numbers: | 03-134, 03-134 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by North Shore Long Island Jewish Health System:
|
early intervention social functioning role functioning cognition |
Additional relevant MeSH terms:
|
Schizotypal Personality Disorder Mental Disorders Psychotic Disorders Schizophrenia Personality Disorders Schizophrenia and Disorders with Psychotic Features Aripiprazole Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013