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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Feinstein Institute for Medical Research.
Recruitment status was  Not yet recruiting
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

July 1, 2010
May 27, 2011
June 2011
September 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01155544 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Substance Abuse
  • Substance Dependence
Behavioral: Behavioral Intervention
Preventing recurrence of substance use.
  • Active Comparator: Aripiprazole
    Intervention: Behavioral: Behavioral Intervention
  • Placebo Comparator: Placebo
    Intervention: Behavioral: Behavioral Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
June 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
16 Years to 44 Years
No
Contact: Christina E Ryan, B.A. 718-470-4255 cryan3@nshs.edu
Contact: Serge Sevy, MD, MBA 718-470-8175 sevy@lij.edu
United States
 
NCT01155544
10-160B
Yes
Serge Sevy, MD, MBA, Feinstein Institute for Medical Research
Feinstein Institute for Medical Research
National Institute of Mental Health (NIMH)
Principal Investigator: Serge Sevy, MD, MBA Feinstein Institute for Medical Research
Feinstein Institute for Medical Research
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP