Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder

NCT00130923 | Completed Phase 4 Results DMC

• 2 other identifiers: 17359RIS-EMR-4032
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.

Conditions

Schizophrenia; Psychotic Disorders; Substance Abuse; Alcohol Abuse

Keywords

Risperidone; Schizophrenia; Substance Use Disorder; Alcohol Use Disorder; Treatment; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)

  Frequency of heavy drinking days is obtained each week retrospectively as the number of heavy drinking days during the prior week (assessed by the Timeline Followback Scale). A heavy drinking day is defined as 4 or more drinks per day for a female and 5 or more drinks per day for a male. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.

  6 months

Secondary Outcomes (5)

• Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy)

  6 months

• Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy)

  6 months

• Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy)

  6 months

• Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy)

  6 months

• Number of Participants With Medication Adherence

  6 months

Study Arms (2)

Risperidone Long Acting

EXPERIMENTAL

Risperidone Long Acting; aka Risperdal Consta; injectable form

Drug: Risperidone Long Acting

Oral Risperidone

ACTIVE COMPARATOR

Oral Risperidone; aka Risperdal; oral form

Drug: oral risperidone

Interventions

Risperidone Long Acting DRUG

Dose 25.00, 37.50 or 50.00 mg q two weeks

Also known as: Risperdal Consta

Risperidone Long Acting

oral risperidone DRUG

0.50-6.00 mg oral risperidone daily

Also known as: Risperdal

Oral Risperidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Schizophrenia or schizoaffective disorder
• Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use disorder
• Alcohol use on at least 5 days during the 4 weeks prior to randomization
• Patient is medically stable to start either form of risperidone.

You may not qualify if:

• Current treatment with clozapine.
• Current treatment with injectable risperidone long-acting.
• Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
• Change in medications (dose of current medication, discontinuation of medication, or new medication) in past 30 days.
• History of or current breast cancer.
• History of intolerance of or allergy to risperidone or risperidone long-acting.
• Currently residing in a residential program designed to treat substance use disorders.
• Current treatment with long-acting, injectable antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
• Past treatment with risperidone long-acting will require a review by the medication adjustment group before entering the client into the study.
• Treatment at baseline with a second antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
• Treatment at baseline with a psychotropic agent proposed to curtail substance use will require a review by the medication adjustment group before entering the client into the study.
• Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Janssen, LP: collaborator

Study Sites (8)

JMH Mental Health Center, University of Miami

Miami, Florida, 33136, United States

Location

School of Pharmacy, Univ. of Missouri Kansas City

Kansas City, Missouri, 64108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

West Central Behavioral Health

Lebanon, New Hampshire, 03766, United States

Location

Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03101, United States

Location

Center for Psychiatric Advancement

Nashua, New Hampshire, 03060, United States

Location

University of South Carolina

Columbia, South Carolina, 29203, United States

Location

White River Junction Veterans Admininistration Medical Center

White River Junction, Vermont, 05009, United States

Location

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Substance-Related Disorders; Alcoholism

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mary Brunette
• Organization: Psychopharmacology Research Group

mary.f.brunette@hitchcock.org

603-271-5747

Study Officials

• Alan I. Green, MD

  Dartmouth Medical School, Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2005
• First Posted: August 16, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2010
• Last Updated: May 9, 2019
• Results First Posted: October 24, 2012

Record last verified: 2019-04

Locations

US (8)