Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
| Status: | Withdrawn |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 16 - 44 |
| Updated: | 4/17/2018 |
| Start Date: | June 2011 |
| End Date: | June 2014 |
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 with psychotic disorder not otherwise specified (PNOS) or
substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is
known about the most appropriate maintenance/relapse prevention management of these subjects.
These individuals are not diagnosed with a primary psychosis because psychotic symptoms are
too short-lived or non-specific, the onset of substance use precedes the onset of psychotic
symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of
substance use. However, previous studies have shown that they are at high risk of recurrence
of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation
antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic
episode of short duration associated with substance use. The investigators will compare
aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing
substance use during a 6-month maintenance phase.
episodes of short duration (less than four weeks) while using substances. This includes
individuals diagnosed with psychotic disorder not otherwise specified (PNOS) or
substance-induced psychotic disorder (SIP) AND substance abuse or dependence. Very little is
known about the most appropriate maintenance/relapse prevention management of these subjects.
These individuals are not diagnosed with a primary psychosis because psychotic symptoms are
too short-lived or non-specific, the onset of substance use precedes the onset of psychotic
symptoms and the subject has not experienced sufficient psychotic symptoms in the absence of
substance use. However, previous studies have shown that they are at high risk of recurrence
of psychotic symptoms. Thus, this project will assess the efficacy of the second-generation
antipsychotic aripiprazole for maintenance treatment of subjects who had a recent psychotic
episode of short duration associated with substance use. The investigators will compare
aripiprazole and placebo for preventing the recurrence of psychotic symptoms and decreasing
substance use during a 6-month maintenance phase.
Inclusion Criteria:
- 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 Criteria:
- 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.
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