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

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00130923
First received: August 15, 2005
Last updated: September 23, 2012
Last verified: September 2012
Results First Received: July 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Psychotic Disorders
Substance Abuse
Alcohol Abuse
Interventions: Drug: Risperidone Long Acting
Drug: oral risperidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Risperidone Long Acting Injectable (LAI) Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
Oral Risperidone Aka Risperal Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.

Participant Flow:   Overall Study
    Risperidone Long Acting Injectable (LAI)     Oral Risperidone Aka Risperal  
STARTED     49     46  
COMPLETED     36     32  
NOT COMPLETED     13     14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Risperidone Long Acting Injectable (LAI) Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
Oral Risperidone Aka Risperal Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
Total Total of all reporting groups

Baseline Measures
    Risperidone Long Acting Injectable (LAI)     Oral Risperidone Aka Risperal     Total  
Number of Participants  
[units: participants]
  49     46     95  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     49     46     95  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.7  ± 10.1     41.7  ± 11.5     41.70  ± 10.7  
Gender  
[units: participants]
     
Female     12     10     22  
Male     37     36     73  
Region of Enrollment  
[units: participants]
     
United States     49     46     95  



  Outcome Measures

1.  Primary:   Mean Heavy Drinking Days Per Week   [ Time Frame: 6 months ]

2.  Secondary:   Other Substance Use as Assessed by the Timeline Followback Scale   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mary Brunette
Organization: Psychopharmacology Research Group
phone: 603-271-5747
e-mail: mary.f.brunette@hitchcock.org


Publications:
Albanese M. Risperidone in substance abusers with bipolar disorder. Presented at the 39th Annual Meeting of the American College of Neuropsychopharmacology. Sa Juan, PR, 2000.
Akaike, H, Information theory and an extension of the maximum likelihood principle., in 2nd International Symposium on Information Theory and Control., EBN Petrovand & C. Csaki, Editors. 1973, Akademia Kiado: Budapest, p. 267-281.
Buckley P, McCarthy M, Chapman P, Richman C, Yamamoto B. Clozapine treatment of comorbid substance abuse in patients with schizophrenia. Schizophr Res 1999, 36:272.
Lee, ET. Statistical Methods for Survival Analysis. 1992, New York: John Wiley & Sons.
Tukey, JW. Exploratory Data Analysis. 1977, Reading, MA: Addison Wesley Publ. Co.
Waternaux, C, Laird, N, Ware, J. Methods for the analysis of longitudinal data: Blood concentrations and cognitive development. J.Amer. Stat. Assoc. 1989: 84, p.33-41.


Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00130923     History of Changes
Other Study ID Numbers: 17359, RIS-EMR-4032
Study First Received: August 15, 2005
Results First Received: July 23, 2012
Last Updated: September 23, 2012
Health Authority: United States: Institutional Review Board