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Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT01631682
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Orr, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions Posttraumatic Stress Disorder
Anxiety Disorder
Interventions Drug: Propranolol
Behavioral: Reactivation
Drug: Mifepristone
Drug: Intranasal oxytocin
Enrollment 186
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin
Hide Arm/Group Description

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

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)

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

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

Period Title: Overall Study
Started 55 66 44 7
Completed 24 21 13 5
Not Completed 31 45 31 2
Arm/Group Title Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin Total
Hide Arm/Group Description

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

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)

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

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 of all reporting groups
Overall Number of Baseline Participants 24 21 13 5 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 13 participants 5 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
21
 100.0%
13
 100.0%
5
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 21 participants 13 participants 5 participants 63 participants
22.6  (3.2) 23.1  (2.6) 23.2  (4.5) 22.8  (3.3) 22.9  (3.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 13 participants 5 participants 63 participants
Female
12
  50.0%
10
  47.6%
7
  53.8%
5
 100.0%
34
  54.0%
Male
12
  50.0%
11
  52.4%
6
  46.2%
0
   0.0%
29
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 21 participants 13 participants 5 participants 63 participants
24 21 13 5 63
Spider Phobia Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 24 participants 21 participants 13 participants 5 participants 63 participants
8.0  (1.8) 7.6  (2.0) 8.0  (2.5) 7.0  (2.6) 7.7  (2.2)
[1]
Measure Description: Range of scores = 0-15. Higher score represents greater fear of spiders.
1.Primary Outcome
Title Change From Baseline Skin Conductance Response
Hide Description 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.
Time Frame 48hrs
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin
Hide Arm/Group Description:

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

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)

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

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 Number of Participants Analyzed 24 21 13 5
Mean (Standard Deviation)
Unit of Measure: microSiemens
.06  (.34) .17  (.44) -1.27  (1.68) -.04  (.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propranolol
Comments This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reactivation With Time Delay
Comments This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mifepristone
Comments This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Intranasal Oxytocin
Comments This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Within 24 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin
Hide Arm/Group Description

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

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)

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

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

All-Cause Mortality
Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/21 (0.00%)      0/13 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propranolol Reactivation With Time Delay Mifepristone Intranasal Oxytocin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/21 (0.00%)      2/13 (15.38%)      0/5 (0.00%)    
General disorders         
Mild Nausea * 1 [1]  0/24 (0.00%)  0 0/21 (0.00%)  0 2/13 (15.38%)  2 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Mild nausea
[1]
Mild nausea, possibly related to the medication.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Scott P. Orr, Ph.D.
Organization: Massachusetts General Hospital
Phone: 617-643-7269
Responsible Party: Scott Orr, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01631682     History of Changes
Other Study ID Numbers: W81XWH-11-2-0092
First Submitted: June 25, 2012
First Posted: June 29, 2012
Results First Submitted: September 13, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017