Trial Outcomes & Findings for Psychosocial and Medication Treatment for Anxiety in Alcoholism (NCT NCT00248612)
NCT ID: NCT00248612
Last Updated: 2018-01-24
Results Overview
Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
162 participants
Primary outcome timeframe
Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)
Results posted on
2018-01-24
Participant Flow
Following telephone screening (n=950), 162 eligible subjects completed an in-clinic baseline assessment #1 to determine eligibility for inclusion in the study.
Once subjects achieved the four day period of abstinence they completed a second baseline assessment in which eligibility was re-assessed. 81 Eligible subjects were then randomized into the four study arms.
Participant milestones
| Measure |
Venlafaxine & CBT
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper. They will also receive tailored cognitive behavioral training (CBT)
|
Placebo & CBT
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
Venlafaxine and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
14
|
22
|
|
Overall Study
COMPLETED
|
24
|
21
|
14
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychosocial and Medication Treatment for Anxiety in Alcoholism
Baseline characteristics by cohort
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Venlafaxine and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
Total
n=81 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Drinking status
percent days drinking
|
72.0 percent of days
STANDARD_DEVIATION 24.5 • n=5 Participants
|
76.0 percent of days
STANDARD_DEVIATION 25.6 • n=7 Participants
|
88.0 percent of days
STANDARD_DEVIATION 12.7 • n=5 Participants
|
76.5 percent of days
STANDARD_DEVIATION 25.8 • n=4 Participants
|
77 percent of days
STANDARD_DEVIATION 23.8 • n=21 Participants
|
|
Drinking status
percent days heavy drinking
|
63.1 percent of days
STANDARD_DEVIATION 28.0 • n=5 Participants
|
59.1 percent of days
STANDARD_DEVIATION 33.7 • n=7 Participants
|
76.9 percent of days
STANDARD_DEVIATION 19.1 • n=5 Participants
|
67.2 percent of days
STANDARD_DEVIATION 28.6 • n=4 Participants
|
65.6 percent of days
STANDARD_DEVIATION 28.2 • n=21 Participants
|
|
ADS Scores
|
15.0 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
16.1 units on a scale
STANDARD_DEVIATION 5.9 • n=4 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Drinks per day
|
8.4 number of drinks
STANDARD_DEVIATION 6.5 • n=5 Participants
|
7.0 number of drinks
STANDARD_DEVIATION 4.6 • n=7 Participants
|
9.6 number of drinks
STANDARD_DEVIATION 4.3 • n=5 Participants
|
9.7 number of drinks
STANDARD_DEVIATION 7.5 • n=4 Participants
|
8.6 number of drinks
STANDARD_DEVIATION 6.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Clinical Global Impression Scale-I (CGI-I)
Session 1 CGI-I
|
3.65 units on a scale
Standard Deviation 1.34
|
3.81 units on a scale
Standard Deviation 1.21
|
3.86 units on a scale
Standard Deviation 1.10
|
4.05 units on a scale
Standard Deviation 0.65
|
|
Clinical Global Impression Scale-I (CGI-I)
Session 8 CGI-I
|
3.61 units on a scale
Standard Deviation 1.38
|
3.13 units on a scale
Standard Deviation 0.89
|
3.50 units on a scale
Standard Deviation 1.09
|
3.53 units on a scale
Standard Deviation 1.19
|
|
Clinical Global Impression Scale-I (CGI-I)
Session 11 CGI-I
|
3.13 units on a scale
Standard Deviation 1.30
|
2.61 units on a scale
Standard Deviation 0.78
|
3.00 units on a scale
Standard Deviation 1.15
|
2.92 units on a scale
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time? (1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Clinical Global Impression Scale-S (CGI-S)
Session 8 CGI-S
|
3.28 units on a scale
Standard Deviation 1.49
|
2.88 units on a scale
Standard Deviation 1.26
|
3.25 units on a scale
Standard Deviation 1.42
|
3.40 units on a scale
Standard Deviation 1.18
|
|
Clinical Global Impression Scale-S (CGI-S)
Session 11 CGI-S
|
3.00 units on a scale
Standard Deviation 1.88
|
2.53 units on a scale
Standard Deviation 1.18
|
2.60 units on a scale
Standard Deviation 1.51
|
2.85 units on a scale
Standard Deviation 1.34
|
|
Clinical Global Impression Scale-S (CGI-S)
Session 1 CGI-S
|
4.00 units on a scale
Standard Deviation 1.24
|
3.76 units on a scale
Standard Deviation 0.89
|
3.93 units on a scale
Standard Deviation 0.92
|
4.18 units on a scale
Standard Deviation 1.18
|
PRIMARY outcome
Timeframe: 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)The Craving Desire Scale (CDS) is a 3-item scale ("1. I do want to drink now", "2. I crave a drink right now", 3. "I have a desire for a drink right now") used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Craving Desire Scale (CDS)
Session 1 CDS
|
8.63 units on a scale
Standard Deviation 6.03
|
8.14 units on a scale
Standard Deviation 5.02
|
8.21 units on a scale
Standard Deviation 5.94
|
7.55 units on a scale
Standard Deviation 5.06
|
|
Craving Desire Scale (CDS)
Session 8 CDS
|
6.44 units on a scale
Standard Deviation 5.28
|
7.41 units on a scale
Standard Deviation 5.06
|
4.45 units on a scale
Standard Deviation 1.75
|
5.56 units on a scale
Standard Deviation 3.41
|
|
Craving Desire Scale (CDS)
Session 11 CDS
|
4.38 units on a scale
Standard Deviation 1.94
|
6.11 units on a scale
Standard Deviation 4.76
|
5.10 units on a scale
Standard Deviation 2.08
|
4.25 units on a scale
Standard Deviation 2.70
|
PRIMARY outcome
Timeframe: Session 8 (8 weeks of treatment)Abstaining from the consumption of intoxicating beverages.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Number of Participants Abstinent
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe number and percent of participants that completed the treatment in each arm of the study.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Treatment Completion
|
18 Participants
|
17 Participants
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Medication Compliance Rates
|
96.89 percentage of participants
|
97.06 percentage of participants
|
88.70 percentage of participants
|
95.39 percentage of participants
|
SECONDARY outcome
Timeframe: Session 1 (baseline), Session 11 (11 weeks of treatment)DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
DASS Stress Subscale Score
Session 11 DASS stress subscale
|
8.1 units on a scale
Standard Deviation 4.6
|
9.6 units on a scale
Standard Deviation 7.9
|
4.1 units on a scale
Standard Deviation 7.9
|
11.2 units on a scale
Standard Deviation 11.1
|
|
DASS Stress Subscale Score
Session 1 DASS stress subscale
|
16.7 units on a scale
Standard Deviation 7.6
|
19.2 units on a scale
Standard Deviation 9.1
|
21.5 units on a scale
Standard Deviation 11.3
|
16.6 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Session 1 (baseline), Session 8 (8 weeks of treatment)The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where \<17 indicates mild anxiety, 18-24 moderate anxiety and 25-30 severe anxiety. Higher scores reflect more anxiety.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
HAM-A Scale
Session 8 HAM-A
|
9.8 units on a scale
Standard Deviation 6.9
|
9.1 units on a scale
Standard Deviation 5.5
|
7.9 units on a scale
Standard Deviation 5.5
|
9.1 units on a scale
Standard Deviation 4.2
|
|
HAM-A Scale
Session 1 HAM-A
|
13.5 units on a scale
Standard Deviation 5.9
|
14.2 units on a scale
Standard Deviation 7.3
|
16.5 units on a scale
Standard Deviation 6.8
|
12.9 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Session 1 (baseline), Session 8 (8 weeks of treatment)HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression.
Outcome measures
| Measure |
Venlafaxine & CBT
n=24 Participants
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 Participants
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 Participants
Placebo medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 Participants
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
HAM-D Scale
Session 1 HAM-D
|
12.0 units on a scale
Standard Deviation 5.7
|
11.7 units on a scale
Standard Deviation 6.0
|
13.0 units on a scale
Standard Deviation 7.2
|
13.6 units on a scale
Standard Deviation 5.0
|
|
HAM-D Scale
Session 8 HAM-D
|
8.8 units on a scale
Standard Deviation 6.6
|
8.5 units on a scale
Standard Deviation 4.6
|
5.9 units on a scale
Standard Deviation 5.6
|
10 units on a scale
Standard Deviation 6.2
|
Adverse Events
Venlafaxine & CBT
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & CBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Venlafaxine & PMR
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & PMR
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venlafaxine & CBT
n=24 participants at risk
Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
|
Placebo & CBT
n=21 participants at risk
Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
|
Venlafaxine & PMR
n=14 participants at risk
Venlafaxine medication and PMR (progressive muscle relaxation therapy).
|
Placebo & PMR
n=22 participants at risk
Placebo medication and PMR (progressive muscle relaxation therapy)
|
|---|---|---|---|---|
|
Psychiatric disorders
suicidal ideation
|
12.5%
3/24 • Number of events 3 • 12 months
|
0.00%
0/21 • 12 months
|
7.1%
1/14 • Number of events 1 • 12 months
|
0.00%
0/22 • 12 months
|
|
Gastrointestinal disorders
nausea
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/14 • 12 months
|
0.00%
0/22 • 12 months
|
|
General disorders
insomnia
|
0.00%
0/24 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/14 • 12 months
|
0.00%
0/22 • 12 months
|
|
Psychiatric disorders
agitation/restlessness
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/21 • 12 months
|
7.1%
1/14 • Number of events 1 • 12 months
|
0.00%
0/22 • 12 months
|
|
Psychiatric disorders
depression
|
4.2%
1/24 • Number of events 1 • 12 months
|
4.8%
1/21 • Number of events 1 • 12 months
|
7.1%
1/14 • Number of events 1 • 12 months
|
0.00%
0/22 • 12 months
|
|
Psychiatric disorders
anxiety
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/21 • 12 months
|
7.1%
1/14 • Number of events 1 • 12 months
|
0.00%
0/22 • 12 months
|
|
General disorders
elevated blood pressure
|
0.00%
0/24 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/14 • 12 months
|
4.5%
1/22 • Number of events 1 • 12 months
|
|
General disorders
profuse sweating
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/14 • 12 months
|
0.00%
0/22 • 12 months
|
|
General disorders
vertigo
|
4.2%
1/24 • Number of events 1 • 12 months
|
0.00%
0/21 • 12 months
|
0.00%
0/14 • 12 months
|
0.00%
0/22 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Todd J. Farchione, PhD
Center for Anxiety and Related Disorders at Boston University
Phone: 617 353 9610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place