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

April 16, 2019 updated by: Alan Green, Dartmouth-Hitchcock Medical Center

Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. In addition, medication non-compliance is common among patients with schizophrenia.

Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia. A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders. Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents, improving negative symptoms and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable medication addresses issues of noncompliance, while avoiding peak blood levels of oral preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia. Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system.

This study is an open, randomized, controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use. Patients with schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • JMH Mental Health Center, University of Miami
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • School of Pharmacy, Univ. of Missouri Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • West Central Behavioral Health
      • Manchester, New Hampshire, United States, 03101
        • Mental Health Center of Greater Manchester
      • Nashua, New Hampshire, United States, 03060
        • Center for Psychiatric Advancement
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • University of South Carolina
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • White River Junction Veterans Admininistration Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Risperidone Long Acting
Risperidone Long Acting; aka Risperdal Consta; injectable form
Drug: Risperidone Long Acting
Dose 25.00, 37.50 or 50.00 mg q two weeks
Other Names:
  • Risperdal Consta
ACTIVE_COMPARATOR: Oral Risperidone
Oral Risperidone; aka Risperdal; oral form
Drug: oral risperidone
0.50-6.00 mg oral risperidone daily
Other Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy)
Time Frame: 6 months
Frequency of drinking days is obtained each week retrospectively as the number of drinking days during the prior week (assessed using the Timeline Followback). 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
Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy)
Time Frame: 6 months
A rater assesses the severity of illness and global impression using a scale from 1 to 7 (Clinical Global Impression), where higher values represent a worse outcome. 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
Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy)
Time Frame: 6 months
A rater assesses positive and negative symptoms of schizophrenia using a 30-item scale (Positive and Negative Symptom Score) Scores range from 30 to 210, where higher values represent a worse outcome. 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
Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy)
Time Frame: 6 months
A rater assesses social, occupational and psychological functioning on a hypothetical continuum of mental health - illness (using Global Assessment of Functioning); scores range from 100 to 1, where higher values represent a better outcome. 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
Number of Participants With Medication Adherence
Time Frame: 6 months
Number of participants with medication adherence (defined as taking medication at least 75% of the days in the treatment period).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Janssen, LP

Investigators

  • Principal Investigator: Alan I. Green, MD, Dartmouth Medical School, Dartmouth College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (ESTIMATE)

August 16, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17359
  • RIS-EMR-4032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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