Trial Outcomes & Findings for Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders (NCT NCT01631682)
NCT ID: NCT01631682
Last Updated: 2017-02-23
Results Overview
Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
186 participants
Primary outcome timeframe
48hrs
Results posted on
2017-02-23
Participant Flow
186 individuals initially signed a consent form. Of these 186 individuals who gave signed consent, 14 had unmeasureable skin conductance levels and were not able to participate in the study, leaving 172 individuals who participated.
Participant milestones
| Measure |
Propranolol
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill
|
Reactivation With Time Delay
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.
Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
|
Mifepristone
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets
|
Intranasal Oxytocin
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
66
|
44
|
7
|
|
Overall Study
COMPLETED
|
24
|
21
|
13
|
5
|
|
Overall Study
NOT COMPLETED
|
31
|
45
|
31
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders
Baseline characteristics by cohort
| Measure |
Propranolol
n=24 Participants
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill
|
Reactivation With Time Delay
n=21 Participants
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction
Reactivation: subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
|
Mifepristone
n=13 Participants
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets
|
Intranasal Oxytocin
n=5 Participants
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril
|
Total
n=63 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
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
63 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
|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
23.1 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
23.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
22.8 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
22.9 years
STANDARD_DEVIATION 3.4 • n=21 Participants
|
|
Gender
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
13 participants
n=5 Participants
|
5 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Spider Phobia Questionnaire
|
8.0 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.6 • n=4 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 2.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: 48hrsSkin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.
Outcome measures
| Measure |
Propranolol
n=24 Participants
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill
|
Reactivation With Time Delay
n=21 Participants
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.
Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
|
Mifepristone
n=13 Participants
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets
|
Intranasal Oxytocin
n=5 Participants
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril
|
|---|---|---|---|---|
|
Change From Baseline Skin Conductance Response
|
.06 microSiemens
Standard Deviation .34
|
.17 microSiemens
Standard Deviation .44
|
-1.27 microSiemens
Standard Deviation 1.68
|
-.04 microSiemens
Standard Deviation .27
|
Adverse Events
Propranolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reactivation With Time Delay
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mifepristone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Intranasal Oxytocin
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 |
Propranolol
n=24 participants at risk
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Propranolol: 40mg single pill
|
Reactivation With Time Delay
n=21 participants at risk
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.
Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
|
Mifepristone
n=13 participants at risk
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Mifepristone: 1800mg, 9 tablets
|
Intranasal Oxytocin
n=5 participants at risk
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril
|
|---|---|---|---|---|
|
General disorders
Mild Nausea
|
0.00%
0/24 • Within 24 hours.
|
0.00%
0/21 • Within 24 hours.
|
15.4%
2/13 • Number of events 2 • Within 24 hours.
|
0.00%
0/5 • Within 24 hours.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place