Clinical trial NCT00169949: Aripiprazole Treatment of the Prodrome
Official title: Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prodromal Schizophrenia
Prodromal Psychosis
Keywords: early intervention
social functioning
role functioning
cognition
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Score on attenuated positive symptom scale at 12 weeks
measure: Score on attenuated negative symptom scale at 12 weeks
measure: Score on adverse events rating scale at 12 weeks
Secondary outcomes:
measure: Score on social functioning scale at 12 weeks
measure: Score on academic functioning scale at 12 weeks
measure: Score on cognitive measures at 12 weeks
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: LIJMC
name: Barbara Cornblatt, PhD
role: PRINCIPAL_INVESTIGATOR
References: