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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01155544
Recruitment Status : Withdrawn (Seems to have simply stopped.)
First Posted : July 2, 2010
Last Update Posted : March 19, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Northwell Health

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 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 or disease Intervention/treatment Phase
Substance Abuse Substance Dependence Behavioral: Behavioral Intervention Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Outcomes in Psychosis Associated With Substance Use Using Aripiprazole
Study Start Date : June 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Aripiprazole Behavioral: Behavioral Intervention
Preventing recurrence of substance use.

Placebo Comparator: Placebo Behavioral: Behavioral Intervention
Preventing recurrence of substance use.

Primary Outcome Measures :
  1. Psychotic Symptoms [ Time Frame: 7 months ]
    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.

  2. Frequency/amount of substance use [ Time Frame: 7 months ]
    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 :
  1. Mood symptoms [ Time Frame: 7 months ]
    Mood symptoms will be assessed with the Hamilton Depression Rating Scale

  2. Adverse Events [ Time Frame: 7 months ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01155544

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United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
North Shore Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
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Principal Investigator: Serge Sevy, MD, MBA Feinstein Institute for Medical Research
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Responsible Party: Northwell Health Identifier: NCT01155544    
Other Study ID Numbers: 10-160B
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by Northwell Health:
Psychotic experiences
Substance abuse
Substance dependence
Substance use
Additional relevant MeSH terms:
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Substance-Related Disorders
Mental Disorders
Chemically-Induced Disorders