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Trial record 11 of 47 for:    DESIPRAMINE

Risperidone and Desipramine in Alcohol Use and Schizophrenia (RADIAUS)

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ClinicalTrials.gov Identifier: NCT01411085
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
University of South Carolina
University of Massachusetts, Worcester
Michigan State University
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Alcoholism
Dual Diagnosis
Intervention Drug: Risperidone + Desipramine
Enrollment 12
Recruitment Details  
Pre-assignment Details Two participants were enrolled in a risperidone + placebo arm, but in 6/2013 the design of the study was changed to include only the risperidone + desipramine arm.
Arm/Group Title Risperidone + Desipramine
Hide Arm/Group Description All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone and paliperidone palmitate) at the time that treatment with desipramine was initiated. The target of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
Period Title: Overall Study
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Physician Decision             1
Protocol Violation             1
Adverse Event             1
Arm/Group Title Risperidone + Desipramine
Hide Arm/Group Description All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate) at the time treatment with desipramine was initiated. The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
7 completers in the risperidone + desipramine group were analyzed. 3 study subjects in the risperidone + desipramine group did not have sufficient days in study for analysis.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
[1]
Measure Analysis Population Description: 10 study subjects were enrolled.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
46  (9.82)
[1]
Measure Analysis Population Description: 10 study subjects were enrolled.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
1
  10.0%
Male
9
  90.0%
[1]
Measure Analysis Population Description: 10 study subjects were enrolled.
Region of Enrollment   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
[1]
Measure Description: Timeline Followback assessment of drinks per week
[2]
Measure Analysis Population Description: 10 study subjects were enrolled.
1.Primary Outcome
Title Timeline Followback Assessing Number of Drinks Per Week
Hide Description Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.
Time Frame Weekly for 14 weeks, using data from last 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all completers (N=7).
Arm/Group Title Risperidone + Desipramine
Hide Arm/Group Description:
All participants were treated with risperidone (or a risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate). The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Drinks per week
35.9  (20.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone + Desipramine
Comments The assessment was between baseline and values for last 8 weeks.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.0
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risperidone + Desipramine
Hide Arm/Group Description

All participants were treated with risperidone (or a risperidone-like agent including: risperidone long-acting, paliperdione, and paliperidone palmitate) at the time treatment with desipramine is initiated. The target dose of oral risperidone is 4mg/day though variations were allowed. The target dose of desipramine was 100mg/day.

Risperidone + Desipramine

All-Cause Mortality
Risperidone + Desipramine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone + Desipramine
Affected / at Risk (%) # Events
Total   3/10 (30.00%)    
Psychiatric disorders   
Suicidal ideation  1/10 (10.00%)  1
Suicide atttempt  1/10 (10.00%)  1
Alcohol intoxication  1/10 (10.00%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Risperidone + Desipramine
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Cardiac disorders   
Hypertension   1/10 (10.00%)  1
Right bundle branch   1/10 (10.00%)  1
Sinus tachycardia   1/10 (10.00%)  1
Tachycardia   1/10 (10.00%)  1
Gastrointestinal disorders   
Diarrehea   1/10 (10.00%)  1
Dry Mouth   2/10 (20.00%)  2
Increased appetite   1/10 (10.00%)  1
Stomach pain   2/10 (20.00%)  3
GERD   1/10 (10.00%)  1
General disorders   
Dizziness   1/10 (10.00%)  1
Irritability   1/10 (10.00%)  1
Infections and infestations   
Gum Infection   1/10 (10.00%)  1
Upper Respiratory Infection   1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Fall   2/10 (20.00%)  2
Investigations   
Abnormal ECG   1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Neck pain   1/10 (10.00%)  1
Nervous system disorders   
Lethargy   1/10 (10.00%)  1
Involuntary movements   1/10 (10.00%)  1
Tremor   1/10 (10.00%)  1
Psychiatric disorders   
Anxiety   1/10 (10.00%)  2
Depression   1/10 (10.00%)  1
Insomnia   1/10 (10.00%)  1
Libido decrease   1/10 (10.00%)  1
Alcohol intoxication   1/10 (10.00%)  7
Respiratory, thoracic and mediastinal disorders   
Nasal Congestion   1/10 (10.00%)  1
Vascular disorders   
Orthostatic Hypotension   4/10 (40.00%)  6
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Alan I Green, MD
Organization: Geisel School of Medicine at Dartmouth
Phone: 603-650-7549
EMail: alan.i.green@dartmouth.edu
Layout table for additonal information
Responsible Party: Alan Green, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01411085     History of Changes
Other Study ID Numbers: 1R21AA019534-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2011
First Posted: August 8, 2011
Results First Submitted: February 22, 2017
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018