Trial Outcomes & Findings for Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder (NCT NCT00662259)
NCT ID: NCT00662259
Last Updated: 2019-07-25
Results Overview
Extent of activation a brain signal when matching emotional face expressions as a percentage of the brain signal when matching geometric designs. The brain signal is the blood oxygen level dependent signal measured by functional magnetic resonance imaging.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
0,1,28 days
Results posted on
2019-07-25
Participant Flow
Participant milestones
| Measure |
Alprazolam
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
11
|
|
Overall Study
COMPLETED
|
19
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Alprazolam
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Alprazolam
n=21 Participants
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 Participants
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.63 years
STANDARD_DEVIATION 14.77 • n=5 Participants
|
36.27 years
STANDARD_DEVIATION 14.69 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0,1,28 daysPopulation: 19 out of 21 participants analyzed due to 2 withdrawing from adverse events.
Extent of activation a brain signal when matching emotional face expressions as a percentage of the brain signal when matching geometric designs. The brain signal is the blood oxygen level dependent signal measured by functional magnetic resonance imaging.
Outcome measures
| Measure |
Alprazolam
n=19 Participants
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 Participants
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces
Day 0 (Baseline)
|
.1489 Percent signal change in brain acitivity
Standard Deviation .1529
|
.1074 Percent signal change in brain acitivity
Standard Deviation .1123
|
|
Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces
Day 1
|
.0119 Percent signal change in brain acitivity
Standard Deviation .1050
|
.1404 Percent signal change in brain acitivity
Standard Deviation .0987
|
|
Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces
Day 28
|
.1230 Percent signal change in brain acitivity
Standard Deviation .1366
|
.1699 Percent signal change in brain acitivity
Standard Deviation .1058
|
PRIMARY outcome
Timeframe: 0,1,28 daysPopulation: Nineteen of 21 alprazolam participants analyzed to two subjects withdrawing due to adverse events.
Extent of activation of a brain signal when anticipating the viewing of an emotional picture as a percentage of brain signal when the viewing of an emotional signal is not anticipated. The brain signal is the blood oxygen level dependent signal as measured by functional magnetic resonance imaging.
Outcome measures
| Measure |
Alprazolam
n=19 Participants
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 Participants
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Signal Change in Brain Activity in the Insula When Anticipating the Viewing of Emotional Pictures.
Day 0 (Baseline)
|
.0707 Percent signal change in brain acitivity
Standard Deviation .0322
|
.0724 Percent signal change in brain acitivity
Standard Deviation .0522
|
|
Signal Change in Brain Activity in the Insula When Anticipating the Viewing of Emotional Pictures.
Day 1
|
.0458 Percent signal change in brain acitivity
Standard Deviation .0274
|
.0645 Percent signal change in brain acitivity
Standard Deviation .0310
|
|
Signal Change in Brain Activity in the Insula When Anticipating the Viewing of Emotional Pictures.
Day 28
|
.0596 Percent signal change in brain acitivity
Standard Deviation .0426
|
.0461 Percent signal change in brain acitivity
Standard Deviation .0337
|
SECONDARY outcome
Timeframe: 0, 7, 28 daysPopulation: Nineteen of 21 participants analyzed due to two participants withdrawing due to adverse events.
Measured participant's general anxiety; range 0 - 56; higher scores worse
Outcome measures
| Measure |
Alprazolam
n=19 Participants
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 Participants
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Score on the Hamilton Anxiety Scale
Day 0 (Baseline)
|
27.79 score on a scale
Standard Deviation 5.99
|
28.00 score on a scale
Standard Deviation 5.42
|
|
Score on the Hamilton Anxiety Scale
Day 7
|
13.58 score on a scale
Standard Deviation 6.94
|
22.18 score on a scale
Standard Deviation 6.71
|
|
Score on the Hamilton Anxiety Scale
Day 28
|
10.85 score on a scale
Standard Deviation 6.01
|
20.18 score on a scale
Standard Deviation 8.74
|
SECONDARY outcome
Timeframe: 0, 7, 28 daysMeasured participant's extent of worry; range 16 - 80, higher scores worse
Outcome measures
| Measure |
Alprazolam
n=19 Participants
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 Participants
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Score on the Penn State Worry Scale
Day 0 (Baseline)
|
64.74 score on a scale
Standard Deviation 8.31
|
66.73 score on a scale
Standard Deviation 7.76
|
|
Score on the Penn State Worry Scale
Day 7
|
50.26 score on a scale
Standard Deviation 10.57
|
62.45 score on a scale
Standard Deviation 7.58
|
|
Score on the Penn State Worry Scale
Day 28
|
48.11 score on a scale
Standard Deviation 12.28
|
61.36 score on a scale
Standard Deviation 10.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 7, 28 daysPopulation: Nineteen of 21 participants analyzed due to 2 participants withdrawal due to adverse events.
Measured the level of a participant's depression; 0 - 48; higher scores worse
Outcome measures
| Measure |
Alprazolam
n=19 Participants
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 Participants
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Score on Quick Inventory of Depressive Symptomatology
Day 0 (Baseline)
|
12.42 score on a scale
Standard Deviation 4.90
|
12.09 score on a scale
Standard Deviation 4.35
|
|
Score on Quick Inventory of Depressive Symptomatology
Day 7
|
8.05 score on a scale
Standard Deviation 4.96
|
10.09 score on a scale
Standard Deviation 3.83
|
|
Score on Quick Inventory of Depressive Symptomatology
Day 28
|
6.42 score on a scale
Standard Deviation 3.36
|
9.09 score on a scale
Standard Deviation 3.30
|
Adverse Events
Alprazolam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alprazolam
n=21 participants at risk
Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder.
Alprazolam (Xanax): Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks).
|
Placebo
n=11 participants at risk
A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Placebo: Placebo, bid, p.o. for 28 +/- 2 days.
|
|---|---|---|
|
Psychiatric disorders
Drowsiness
|
4.8%
1/21 • Number of events 1 • From day 0 (baseline) to day 28.
|
0.00%
0/11 • From day 0 (baseline) to day 28.
|
|
Psychiatric disorders
Claustrophobia
|
4.8%
1/21 • Number of events 1 • From day 0 (baseline) to day 28.
|
0.00%
0/11 • From day 0 (baseline) to day 28.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place