Status:
WITHDRAWN
Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Substance Abuse
Substance Dependence
Eligibility:
All Genders
16-44 years
Phase:
PHASE4
Brief Summary
This project focuses on the under-researched group of individuals who develop psychotic episodes of short duration (less than four weeks) while using substances. This includes individuals diagnosed wi...
Eligibility Criteria
Inclusion
- DSM-IV-defined diagnosis of psychosis NOS or substance-induced psychosis assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
- onset of psychotic symptoms following onset of substance use
- current DSM-IV-defined diagnosis of substance abuse or dependence assessed with the SCID-I/P
- duration of the acute psychotic episode less than 4 weeks
- aged 16 to 44
- competent and willing to sign informed consent
- for women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control and not to become pregnant during the study
- at the entry of the maintenance phase, remission of psychotic symptoms defined as 1) simultaneous ratings of \<3 ("mild) on all of the following Brief Psy¬chiatric Rating Scale-Anchored version items (BPRS-A; Woerner et al. 1988): suspiciousness, unusual thought content, hallucinations, conceptual disorganization; and 2) a Clinical Global Impressions Scale (CGI; Guy 1976) Se-verity rating of 3 ("mild") or less.
Exclusion
- DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, shared psychotic disorder, or a major mood disorder (major depression or bipolar mania) with psychotic features
- antipsychotic treatment for more than six months prior to enrollment
- serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- medical condition that requires treatment with a medication that has psychotropic effects
- significant risk of suicidal or homicidal ideation or behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent or participating in study procedures
- history of treatment resistance to aripiprazole
- medical contraindications to aripiprazole
- hypersensitivity to aripiprazole or any component of the products.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01155544
Start Date
June 1 2011
End Date
June 1 2014
Last Update
March 19 2018
Active Locations (2)
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1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
2
North Shore Hospital
Manhasset, New York, United States, 11030