Trial Outcomes & Findings for Atomoxetine in Veterans With Comorbid ADHD/PTSD (NCT NCT02287038)
NCT ID: NCT02287038
Last Updated: 2019-04-03
Results Overview
Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999): The CAARS-S:S is a 26-item questionnaire that assesses symptoms of ADHD in persons aged 18 years or older. T-scores above 65 indicate a likelihood of moderate to severe ADHD symptoms and impairment. The range for the CAARS-S:S is from 0 to 78. A score of 78 would resemble the worst symptoms of ADHD with a score 0 having no symptoms.
COMPLETED
PHASE4
44 participants
Visit 1, (Day1), Visit 4(Day 36), Visit 7 (Day 71)
2019-04-03
Participant Flow
The participants are explained the nature, purpose, and procedure of the study and asked to sign an informed consent that will explain the potential risks and benefits of the study participation. Primary, secondary outcome measures, and physical examination will be conducted at baseline and all subsequent visits by a qualified research clinician.
Week 1: Screening; Week 2 to 5: Phase 1 (ATX in group 1 and placebo in group2); Week 6: Wash-out; Week 7 to 10: Phase 2 (Crossover, Placebo in group1 and ATX in group2).
Participant milestones
| Measure |
Group 1. Atomoxitine First, Then Placebo
Subjects in Group 1: First Intervention (4 weeks with Atomoxetine), Wash-out (1 week), and Second Intervention (4 weeks with placebo)
|
Group 2. Placebo First, Then Atomoxitine
Subjects in Group 1: First Intervention (4 weeks with placebo), Wash-out (1 week), and Second Intervention (4 weeks with Atomoxetine)
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Group 1. Atomoxitine First, Then Placebo
Subjects in Group 1: First Intervention (4 weeks with Atomoxetine), Wash-out (1 week), and Second Intervention (4 weeks with placebo)
|
Group 2. Placebo First, Then Atomoxitine
Subjects in Group 1: First Intervention (4 weeks with placebo), Wash-out (1 week), and Second Intervention (4 weeks with Atomoxetine)
|
|---|---|---|
|
Overall Study
Stopped attending appointments
|
3
|
2
|
|
Overall Study
Anxiety after starting medication
|
0
|
1
|
|
Overall Study
Nausea after starting medication
|
1
|
0
|
|
Overall Study
Abnormal ECG after starting medication
|
1
|
0
|
Baseline Characteristics
The study analyzed 36 participants. 8 participants dropped out of the study.
Baseline characteristics by cohort
| Measure |
Group1
n=23 Participants
Group 1: Atomoxetine during the first phase ( 4 Weeks), the Wash-out (1week), followed by a second phase (4 Weeks) of placebo.
|
Group 2
n=21 Participants
Group 2: Placebo during the first phase ( 4 Weeks), the Wash-out (1week), followed by a second phase (4 Weeks) of Atomoxetine.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
41.2 years
n=23 Participants
|
41.0 years
n=21 Participants
|
41 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=23 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=23 Participants
|
18 Participants
n=21 Participants
|
37 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=23 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=23 Participants
|
20 Participants
n=21 Participants
|
43 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=44 Participants
|
|
CAARS-S:S
|
74.78 units on a scale
STANDARD_DEVIATION 9.54 • n=18 Participants • The study analyzed 36 participants. 8 participants dropped out of the study.
|
69.33 units on a scale
STANDARD_DEVIATION 9.89 • n=18 Participants • The study analyzed 36 participants. 8 participants dropped out of the study.
|
72.06 units on a scale
STANDARD_DEVIATION 9.97 • n=36 Participants • The study analyzed 36 participants. 8 participants dropped out of the study.
|
PRIMARY outcome
Timeframe: Visit 1, (Day1), Visit 4(Day 36), Visit 7 (Day 71)Population: The 36 patients that completed at least one phase of the study were included in the final analyses. The 8 participants did not finish the first phase, and data were not collected on those 8 subjects on the week 4 and week 7. Therefore, the 8 subjects were not entered to the final analysis.
Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999): The CAARS-S:S is a 26-item questionnaire that assesses symptoms of ADHD in persons aged 18 years or older. T-scores above 65 indicate a likelihood of moderate to severe ADHD symptoms and impairment. The range for the CAARS-S:S is from 0 to 78. A score of 78 would resemble the worst symptoms of ADHD with a score 0 having no symptoms.
Outcome measures
| Measure |
Arm1: Atomoxetine
n=36 Participants
This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 1 received Atomoxetine during the first phase, and Group2 receive Atomoxetine in the second phase.
|
Arm 2: Placebo
n=36 Participants
This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 2 received the placebo during the first phase, and Group 1 receive placebo during the second phase.
|
|---|---|---|
|
Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999)
Before the intervention
|
75.12 units on a scale
Standard Deviation 9.23
|
68.56 units on a scale
Standard Deviation 9.34
|
|
Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999)
After the intervention
|
67.79 units on a scale
Standard Deviation 8.79
|
72.80 units on a scale
Standard Deviation 8.91
|
PRIMARY outcome
Timeframe: Visit 1 (Day1), 4(Day 36), 7 (Day 71)Population: The 36 patients that completed at least one phase of the study were included in the final analyses. The 8 participants did not finish the first phase, and data were not collected on those 8 subjects on the week 4 and week 7. Therefore, the 8 subjects were not entered to the final analysis.
The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006): AAQoL-29 is a 29-item questionnaire designed to assess quality of life and was a secondary efficacy measure in this trial. It is a participant-reported outcome measure used to examine disease specific functional impairments and quality of life for adults with ADHD. The AAQoL is scored as an overall total score, measuring Life Productivity, Psycholofical Health, Relationship, and Life Outlook. Each item is rated by patients on a 5-point Likert scale ranging from "Not at all/Never" (1) to "Extremely/Very Often" (5). To derive overall scores, item scores are transformed to a 0-100-point scale (1=0; 2=25; 3=50; 4=75; 5=100). Then, the item scores are summed up and divided by item count to generate overall scores. The score range from 0 to 100. A higher score indicates greater QoL and better functioning.
Outcome measures
| Measure |
Arm1: Atomoxetine
n=36 Participants
This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 1 received Atomoxetine during the first phase, and Group2 receive Atomoxetine in the second phase.
|
Arm 2: Placebo
n=36 Participants
This is a crossover study in which the participants would receive Atomoxetine and Placebo. Group 2 received the placebo during the first phase, and Group 1 receive placebo during the second phase.
|
|---|---|---|
|
The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006)
Before intervention
|
33.61 units on a scale
Standard Deviation 11.52
|
36.51 units on a scale
Standard Deviation 11.18
|
|
The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006)
After Intervention
|
43.51 units on a scale
Standard Deviation 9.80
|
37.23 units on a scale
Standard Deviation 11.12
|
Adverse Events
Arm1, Atomoxetine
Arm2, Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm1, Atomoxetine
n=36 participants at risk
Group 1 received Atomoxetine during the first phase of the study, and Group 2 received Atomoxetine during the second phase.
|
Arm2, Placebo
n=36 participants at risk
Group 2 received the placebo during the first phase of the study, and Group 1 received the placebo during the second phase.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea after starting medication
|
2.8%
1/36 • Number of events 1 • The adverse events were monitored at Week 2 (Day14, Visit 2), week 5 (Day 36, Visit 4), and week 9 (Day 71, Visit 7).
Nausea and Anxiety after starting medication were reported by some of the participants, Majority of participants who had minor Nausea were able to finish the trial. However, two participants dropped out due to Nausea and Anxiety. The two drop out participants were followed up and no further adverse reaction were observed after discontinuation of the trial. One participant had EKG abnormality at screen, and the participant withdraw before the trial.
|
0.00%
0/36 • The adverse events were monitored at Week 2 (Day14, Visit 2), week 5 (Day 36, Visit 4), and week 9 (Day 71, Visit 7).
Nausea and Anxiety after starting medication were reported by some of the participants, Majority of participants who had minor Nausea were able to finish the trial. However, two participants dropped out due to Nausea and Anxiety. The two drop out participants were followed up and no further adverse reaction were observed after discontinuation of the trial. One participant had EKG abnormality at screen, and the participant withdraw before the trial.
|
|
Psychiatric disorders
Anxiety after starting medication
|
2.8%
1/36 • Number of events 1 • The adverse events were monitored at Week 2 (Day14, Visit 2), week 5 (Day 36, Visit 4), and week 9 (Day 71, Visit 7).
Nausea and Anxiety after starting medication were reported by some of the participants, Majority of participants who had minor Nausea were able to finish the trial. However, two participants dropped out due to Nausea and Anxiety. The two drop out participants were followed up and no further adverse reaction were observed after discontinuation of the trial. One participant had EKG abnormality at screen, and the participant withdraw before the trial.
|
0.00%
0/36 • The adverse events were monitored at Week 2 (Day14, Visit 2), week 5 (Day 36, Visit 4), and week 9 (Day 71, Visit 7).
Nausea and Anxiety after starting medication were reported by some of the participants, Majority of participants who had minor Nausea were able to finish the trial. However, two participants dropped out due to Nausea and Anxiety. The two drop out participants were followed up and no further adverse reaction were observed after discontinuation of the trial. One participant had EKG abnormality at screen, and the participant withdraw before the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place