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:

National Institute of Mental Health (NIMH)

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

History of Changes

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:

MedlinePlus related topics: Mental Disorders Psychotic Disorders

Drug Information available for: Aripiprazole

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

National Institute of Mental Health (NIMH)

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:


Aripiprazole Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants Pharmacologic Actions	Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015

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