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:
Feinstein Institute for Medical Research
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
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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 June 17, 2013