Trial Outcomes & Findings for Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism (NCT NCT00452543)
NCT ID: NCT00452543
Last Updated: 2012-07-09
Results Overview
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.
COMPLETED
PHASE4
23 participants
From baseline visit to Week 12 (or early discontinuation visit)
2012-07-09
Participant Flow
Participant milestones
| Measure |
Escitalopram Plus Acamprosate
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
Baseline characteristics by cohort
| Measure |
Escitalopram Plus Acamprosate
n=12 Participants
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 Participants
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
49 years
STANDARD_DEVIATION 13 • n=5 Participants
|
43 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline visit to Week 12 (or early discontinuation visit)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.
Outcome measures
| Measure |
Escitalopram Plus Acamprosate
n=12 Participants
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 Participants
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)
|
-5.6 Scores on a scale
Standard Deviation 8.5
|
-7.8 Scores on a scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)Population: Intent to treat sample
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.
Outcome measures
| Measure |
Escitalopram Plus Acamprosate
n=12 Participants
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 Participants
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Total Drinking Days on the Alcohol Timeline Followback (TLFB)
|
61 Drinking days
Standard Deviation 53 • Interval 8.0 to 114.0
|
61 Drinking days
Standard Deviation 86 • Interval -25.0 to 147.0
|
PRIMARY outcome
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)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.
Outcome measures
| Measure |
Escitalopram Plus Acamprosate
n=12 Participants
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 Participants
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Total Drinks Consumed Per Week on the TLFB
|
15 Drinks consumed per week
Standard Deviation 13 • Interval 2.0 to 28.0
|
15 Drinks consumed per week
Standard Deviation 21 • Interval -6.0 to 36.0
|
PRIMARY outcome
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)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.
Outcome measures
| Measure |
Escitalopram Plus Acamprosate
n=12 Participants
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 Participants
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Total Drinks Consumed Per Drinking Day on the TLFB
|
4 Drinks consumed per drinking day
Standard Deviation 2 • Interval 2.0 to 6.0
|
4 Drinks consumed per drinking day
Standard Deviation 4 • Interval 0.0 to 4.0
|
Adverse Events
Escitalopram Plus Acamprosate
Escitalopram Plus Placebo
Serious adverse events
| Measure |
Escitalopram Plus Acamprosate
n=12 participants at risk
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 participants at risk
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for alcohol intoxication
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Cardiac disorders
Blockage in the coronary artery
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
Other adverse events
| Measure |
Escitalopram Plus Acamprosate
n=12 participants at risk
Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
|
Escitalopram Plus Placebo
n=11 participants at risk
Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Increased gag reflex
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • Number of events 4
|
0.00%
0/11
|
|
General disorders
Dry mouth
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Insomnia
|
8.3%
1/12 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Stomach pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Renal and urinary disorders
Urinary respiratory infection
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
GI upset
|
8.3%
1/12 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Soft stools
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Jaw tightening
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Dry lips
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Increased sweating
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Tension
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place