Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole (SIP)

This study is not yet open for participant recruitment.
Verified June 2010 by Feinstein Institute for Medical Research
Sponsor:
Collaborator:
Information provided by:
Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT01155544
First received: July 1, 2010
Last updated: May 27, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Substance Dependence
Behavioral: Behavioral Intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

Resource links provided by NLM:


Further study details as provided by Feinstein Institute for Medical Research:

Primary Outcome Measures:
  • Psychotic Symptoms [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale. We will focus on time to first recurrence of psychotic symptoms and rate of recurrence.

  • Frequency/amount of substance use [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method. We will focus on time to first recurrence of substance use and rate of recurrence.


Secondary Outcome Measures:
  • Mood symptoms [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Mood symptoms will be assessed with the Hamilton Depression Rating Scale

  • Adverse Events [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Adverse events will be assessed with the Systematic Assessment for Treatment Emergent Events interview, Simpson-Angus Scale for Extrapyramidal Symptoms, the Abnormal Involuntary Movement Scale, the Barnes Akathisia Scale, and blood tests (fasting glucose, insulin and lipid profile tests)


Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aripiprazole Behavioral: Behavioral Intervention
Preventing recurrence of substance use.
Placebo Comparator: Placebo Behavioral: Behavioral Intervention
Preventing recurrence of substance use.

  Eligibility

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155544

Contacts
Contact: Christina E Ryan, B.A. 718-470-4255 cryan3@nshs.edu
Contact: Serge Sevy, MD, MBA 718-470-8175 sevy@lij.edu

Locations
United States, New York
The Zucker Hillside Hospital Not yet recruiting
Glen Oaks, New York, United States, 11004
Contact: Serge Sevy, MD, MBA    718-470-8175    sevy@lij.edu   
Principal Investigator: Serge Sevy, MD, MBA         
North Shore Hospital Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Serge Sevy, MD, MBA    718-470-8175    sevy@lji.edu   
Principal Investigator: Serge Sevy, MD, MBA         
Sponsors and Collaborators
Feinstein Institute for Medical Research
Investigators
Principal Investigator: Serge Sevy, MD, MBA Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: Serge Sevy, MD, MBA, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier: NCT01155544     History of Changes
Other Study ID Numbers: 10-160B
Study First Received: July 1, 2010
Last Updated: May 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Feinstein Institute for Medical Research:
Aripiprazole
Psychotic experiences
Substance abuse
Substance dependence
Craving
Mood
Substance use

Additional relevant MeSH terms:
Psychotic Disorders
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 April 17, 2014