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Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism

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ClinicalTrials.gov Identifier: NCT00452543
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : July 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Janet Melissa Witte, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Alcohol Abuse
Alcohol Dependence
Interventions Drug: acamprosate
Drug: escitalopram
Behavioral: Medical management
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Hide Arm/Group Description Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
Period Title: Overall Study
Started 12 11
Completed 7 5
Not Completed 5 6
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo Total
Hide Arm/Group Description Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
11
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
49  (13) 43  (14) 47  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
4
  33.3%
6
  54.5%
10
  43.5%
Male
8
  66.7%
5
  45.5%
13
  56.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 11 participants 23 participants
12 11 23
1.Primary Outcome
Title Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)
Hide Description Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.
Time Frame From baseline visit to Week 12 (or early discontinuation visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Hide Arm/Group Description:
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-5.6  (8.5) -7.8  (9.9)
2.Primary Outcome
Title Total Drinking Days on the Alcohol Timeline Followback (TLFB)
Hide Description The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit.
Time Frame From Baseline visit to Week 12 (or early discontinuation visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat sample
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Hide Arm/Group Description:
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Drinking days
61  (53) 61  (86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram Plus Acamprosate, Escitalopram Plus Placebo
Comments Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.
Type of Statistical Test Non-Inferiority or Equivalence
Comments This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.
Statistical Test of Hypothesis P-Value <0.05
Comments Threshold for significance was set a priori at p<0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Total Drinks Consumed Per Week on the TLFB
Hide Description Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.
Time Frame From Baseline visit to Week 12 (or early discontinuation visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Hide Arm/Group Description:
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Drinks consumed per week
15  (13) 15  (21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram Plus Acamprosate, Escitalopram Plus Placebo
Comments Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.
Type of Statistical Test Non-Inferiority or Equivalence
Comments This was a test of non-inferiority between the effects of acamprosate vs. placebo.
Statistical Test of Hypothesis P-Value <0.05
Comments This p <0.05 was set a priori.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Total Drinks Consumed Per Drinking Day on the TLFB
Hide Description Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.
Time Frame From Baseline visit to Week 12 (or early discontinuation visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Hide Arm/Group Description:
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Drinks consumed per drinking day
4  (2) 4  (4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram Plus Acamprosate, Escitalopram Plus Placebo
Comments

Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.

Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.

Type of Statistical Test Non-Inferiority or Equivalence
Comments

This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.

Power analysis is discussed above.

Statistical Test of Hypothesis P-Value <0.05
Comments This p<0.05 was set a priori.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Hide Arm/Group Description Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
All-Cause Mortality
Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      0/11 (0.00%)    
Cardiac disorders     
Blockage in the coronary artery  [1]  1/12 (8.33%)  1 0/11 (0.00%)  0
Psychiatric disorders     
Hospitalization for alcohol intoxication  [2]  1/12 (8.33%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject had sudden onset of shortness of breath and chest pain. A blockage was discovered in the coronary artery, requiring that a stent be implanted. The patient was hospitalized for 4 days.
[2]
Subject was admitted to a detox unit after found intoxicated and passed out. Subject was discharged 3 days following from the inpatient unit to an outpatient program.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Plus Acamprosate Escitalopram Plus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      5/11 (45.45%)    
Gastrointestinal disorders     
Increased gag reflex   1/12 (8.33%)  1 0/11 (0.00%)  0
Diarrhea   4/12 (33.33%)  4 0/11 (0.00%)  0
Nausea   2/12 (16.67%)  2 1/11 (9.09%)  1
Stomach pain   1/12 (8.33%)  1 0/11 (0.00%)  0
GI upset   1/12 (8.33%)  1 1/11 (9.09%)  1
Soft stools   1/12 (8.33%)  1 0/11 (0.00%)  0
General disorders     
Dry mouth   1/12 (8.33%)  1 0/11 (0.00%)  0
Insomnia   1/12 (8.33%)  1 2/11 (18.18%)  2
Headache   1/12 (8.33%)  1 2/11 (18.18%)  2
Jaw tightening   0/12 (0.00%)  0 1/11 (9.09%)  1
Dry lips   0/12 (0.00%)  0 1/11 (9.09%)  1
Increased sweating   0/12 (0.00%)  0 1/11 (9.09%)  1
Tension   0/12 (0.00%)  0 1/11 (9.09%)  1
Psychiatric disorders     
Anxiety   0/12 (0.00%)  0 1/11 (9.09%)  1
Renal and urinary disorders     
Urinary respiratory infection   1/12 (8.33%)  1 0/11 (0.00%)  0
Urinary retention   0/12 (0.00%)  0 1/11 (9.09%)  1
Skin and subcutaneous tissue disorders     
Acne   1/12 (8.33%)  1 0/11 (0.00%)  0
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: Dr. Janet Witte
Organization: Massachusetts General Hospital
Phone: 617-726-5104
EMail: jwitte@partners.org
Layout table for additonal information
Responsible Party: Janet Melissa Witte, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00452543    
Other Study ID Numbers: 2006-P-001592/1
First Submitted: March 26, 2007
First Posted: March 27, 2007
Results First Submitted: May 24, 2011
Results First Posted: July 9, 2012
Last Update Posted: July 9, 2012