Trial Outcomes & Findings for A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD (NCT NCT01749215)
NCT ID: NCT01749215
Last Updated: 2021-06-21
Results Overview
Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
151 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2021-06-21
Participant Flow
Participant milestones
| Measure |
Topiramate
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
79
|
|
Overall Study
COMPLETED
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
25
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Topiramate
n=72 Participants
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=79 Participants
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
Total
n=151 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
|
63 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
52.0 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
51.7 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
79 participants
n=7 Participants
|
151 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.
Outcome measures
| Measure |
Topiramate
n=72 Participants
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=79 Participants
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
|
-36.2 percent heavy drinking days
Standard Deviation 0.41
|
-25.1 percent heavy drinking days
Standard Deviation .36
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Data were only collected for N=42 for the Topiramate arm and N=49 for the Placebo arm, as reported here.
The PCL is a 17-item self-report measure reflecting DSM-IV symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". It was calculated by subtracting the data collected at Week 0 (baseline) from data collected at Week 12. Negative scores indicate improvement.
Outcome measures
| Measure |
Topiramate
n=42 Participants
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=49 Participants
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Change in PTSD Symptom Severity as Assessed by the PTSD Checklist (PCL)
|
-15.4 score on a scale
Standard Deviation 14.8
|
-15.9 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Data were only collected for N=22 for the Topiramate arm and N=16 for the Placebo arm, as reported here.
DD measures impulsivity by evaluating discount rates for delayed rewards. On a computer screen, the participant is shown hypothetical dollar amounts that could be received immediately, while a hypothetical $100 reward is displayed continuously. The "delay duration" is the waiting period for the $100 delayed reward. The computer randomly presents each immediate reward dollar amount, one at a time and participants are asked to choose between each immediate reward or the delayed $100. The same procedure will be repeated for each of the delay periods. Delay discounting quantifies the devaluation of rewards over time, which allows for an index of overall discounting rate (k). Higher k values indicate greater discounting and therefore greater impulsivity. DD score change was measured by subtracting Week 0 (baseline) scores from Week 12 scores, with negative scores representing improvement.
Outcome measures
| Measure |
Topiramate
n=22 Participants
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=16 Participants
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Change in Impulsivity as Assessed by Delay Discounting (DD)
|
-0.020 K-value
Standard Deviation 0.34
|
0.058 K-value
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Data were only collected for N=43 for the Topiramate arm and N=46 for the Placebo arm, as reported here.
BART is a computerized measure of risk taking behavior that displays a computer-generated balloon on a computer monitor. Participants gradually pump (inflate) the balloon. Each pump adds 5 cents to a temporary bank. After each pump, participants have 2 options, 1) continue to pump the balloon and risk bursting it, losing all the money from that balloon, or 2) saving the accumulated money to a permanent bank. Whenever a balloon bursts or the participant chooses to bank money, they start with a new balloon. Participants respond to 30 balloons, each having a different bursting point. With each pump, participants weigh the potential gain of collecting more money against the risk of losing all money accumulated with that balloon. Greater number of pumps indicates greater risk taking. Change was calculated by subtracting Week 12 scores from Week 0 (baseline), with negative scores representing improvement and positive scores representing worsening risk taking.
Outcome measures
| Measure |
Topiramate
n=43 Participants
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=46 Participants
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Change in Risk-taking Behavior as Assessed by the Balloon Analogue Risk Task (BART)
|
26.7 Total pumps
Standard Deviation 205.4
|
13.4 Total pumps
Standard Deviation 199.0
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Data were only collected for N=31 for the Topiramate arm and N=34 for the Placebo arm, as reported here.
The Iowa Gambling Task (IGT) is a computerized assessment that evaluates decision-making by tracking the selection of advantageous or disadvantageous electronic cards from four decks. Subjects are presented the 4 decks of cards on a computer screen and are told that they can win money by picking cards from the most advantageous deck. After each deck selection, subjects are provided feedback as to whether their selection resulted in a "win" or a "loss" and the dollar amount of the win/loss. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Change measured by substracting Week 0 (baseline) scores from Week 12 scores. Higher numbers indicate better decision making regarding advantageous cards.
Outcome measures
| Measure |
Topiramate
n=31 Participants
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=34 Participants
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Change in Decision-making Behavior as Assessed by the Iowa Gambling Task (IGT)
|
2.03 test cards
Standard Deviation 13.80
|
2.80 test cards
Standard Deviation 14.54
|
Adverse Events
Topiramate
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 79 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Topiramate
n=72 participants at risk
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=79 participants at risk
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Cardiac disorders
Inpatient hospitalization of less than 24 hours with diagnosis of Type 2 MI
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Inpatient medical hospitalization for alcohol withdrawal.
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Psychiatric disorders
Inpatient psychiatric hospitalization
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Inpatient medical hospitalization due to abdominal pain
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
General disorders
Death of research participant
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Cardiac disorders
Inpatient hospitalization due to congestive heart failure
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Psychiatric disorders
Inpatient hospitalization due to suicidal ideation and alcohol withdrawal
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Respiratory, thoracic and mediastinal disorders
Inpatient hospitalization due to shortness of breath in the setting of abdominal distension
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Respiratory, thoracic and mediastinal disorders
Inpatient hospitalization for lower quadrant pain, cough and chills
|
1.4%
1/72 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
0.00%
0/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Inpatient hospitalization for pancreatitis
|
1.4%
1/72 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
0.00%
0/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Infections and infestations
Inpatient hospitalization for MRSA
|
0.00%
0/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
1.3%
1/79 • Number of events 1 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
Other adverse events
| Measure |
Topiramate
n=72 participants at risk
Topiramate capsules daily - up to 300 mg
Topiramate: Experimental study drug
Medical Management: Brief alcohol counseling
|
Placebo
n=79 participants at risk
Placebo capsules daily - up to 300 mg
placebo: Placebo comparator
Medical Management: Brief alcohol counseling
|
|---|---|---|
|
Nervous system disorders
Numbness or tingling
|
30.6%
22/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
16.5%
13/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Change in sense of taste
|
40.3%
29/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
36.7%
29/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
General disorders
Fatigue
|
23.6%
17/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
21.5%
17/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Loss of appetite
|
52.8%
38/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
29.1%
23/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Difficulty with concentration or attention
|
9.7%
7/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
12.7%
10/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
30/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
35.4%
28/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Ear and labyrinth disorders
Dizziness
|
23.6%
17/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
24.1%
19/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Skin and subcutaneous tissue disorders
Itching
|
36.1%
26/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
26.6%
21/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
General disorders
Sleepiness
|
26.4%
19/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
25.3%
20/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Slow thinking
|
23.6%
17/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
21.5%
17/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Eye disorders
Abnormal vision
|
31.9%
23/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
21.5%
17/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Eye disorders
Eye pain
|
22.2%
16/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
22.8%
18/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Confusion
|
36.1%
26/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
13.9%
11/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Language problems (e.g., word searching)
|
9.7%
7/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
16.5%
13/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Psychiatric disorders
Depression
|
12.5%
9/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
8.9%
7/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Psychiatric disorders
Suicidal thoughts or actions
|
8.3%
6/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
7.6%
6/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Psychiatric disorders
Nervousness
|
9.7%
7/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
12.7%
10/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
|
Nervous system disorders
Difficulty with memory
|
11.1%
8/72 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
13.9%
11/79 • Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
|
Additional Information
Dr. Steven L. Batki
University of California, San Francisco/San Francisco VA Healthcare System
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place