Trial Outcomes & Findings for Oxytocin Administration in BDD and OCD (NCT NCT02671266)
NCT ID: NCT02671266
Last Updated: 2018-11-23
Results Overview
This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
45 minutes post nasal spray administration
Results posted on
2018-11-23
Participant Flow
Participant milestones
| Measure |
Oxytocin, Then Placebo
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
BDD Participants
|
9
|
9
|
|
Overall Study
OCD Participants
|
2
|
3
|
|
Overall Study
Healthy Participants
|
8
|
8
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Oxytocin, Then Placebo
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
BDD-YBOCS was a clinician-administered measure only administered to patients with body dysmorphic disorder.
Baseline characteristics by cohort
| Measure |
Oxytocin, Then Placebo
n=20 Participants
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
n=21 Participants
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.20 years
STANDARD_DEVIATION 8.90 • n=20 Participants
|
27.05 years
STANDARD_DEVIATION 7.00 • n=21 Participants
|
27.12 years
STANDARD_DEVIATION 7.88 • n=41 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
15 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
26 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
38 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=20 Participants
|
14 Participants
n=21 Participants
|
28 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
BDD-YBOCS
|
25.11 units on a scale
STANDARD_DEVIATION 5.13 • n=9 Participants • BDD-YBOCS was a clinician-administered measure only administered to patients with body dysmorphic disorder.
|
24.89 units on a scale
STANDARD_DEVIATION 3.55 • n=9 Participants • BDD-YBOCS was a clinician-administered measure only administered to patients with body dysmorphic disorder.
|
24.89 units on a scale
STANDARD_DEVIATION 4.19 • n=18 Participants • BDD-YBOCS was a clinician-administered measure only administered to patients with body dysmorphic disorder.
|
|
BABS
|
12.73 units on a scale
STANDARD_DEVIATION 5.82 • n=11 Participants • BABS was a clinician-administered measure that was administered to patients with body dysmorphic disorder and obsessive compulsive disorder.
|
11.17 units on a scale
STANDARD_DEVIATION 3.41 • n=12 Participants • BABS was a clinician-administered measure that was administered to patients with body dysmorphic disorder and obsessive compulsive disorder.
|
11.91 units on a scale
STANDARD_DEVIATION 4.67 • n=23 Participants • BABS was a clinician-administered measure that was administered to patients with body dysmorphic disorder and obsessive compulsive disorder.
|
PRIMARY outcome
Timeframe: 45 minutes post nasal spray administrationPopulation: Data reported for BDD and healthy control participants who completed at least one drug visit. There was one patient in the oxytocin first arm who did not complete second placebo drug visit. OCD group was excluded from analyses due to difficulties with recruitment.
This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.
Outcome measures
| Measure |
Oxytocin, Then Placebo
n=17 Participants
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
n=17 Participants
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
|---|---|---|
|
Emotion Recognition Questionnaire
HC oxytocin- other-referent
|
14.78 score on a scale
Standard Deviation 5.74
|
16.25 score on a scale
Standard Deviation 6.90
|
|
Emotion Recognition Questionnaire
BDD oxytocin- self-referent
|
18.67 score on a scale
Standard Deviation 3.16
|
17.00 score on a scale
Standard Deviation 6.41
|
|
Emotion Recognition Questionnaire
BDD placebo- self-referent
|
17.00 score on a scale
Standard Deviation 3.64
|
16.40 score on a scale
Standard Deviation 6.38
|
|
Emotion Recognition Questionnaire
BDD oxytocin- other-referent
|
18.00 score on a scale
Standard Deviation 2.40
|
18.30 score on a scale
Standard Deviation 6.77
|
|
Emotion Recognition Questionnaire
BDD placebo- other-referent
|
18.44 score on a scale
Standard Deviation 2.96
|
16.40 score on a scale
Standard Deviation 6.15
|
|
Emotion Recognition Questionnaire
HC oxytocin- self-referent
|
15.67 score on a scale
Standard Deviation 6.00
|
17.13 score on a scale
Standard Deviation 3.76
|
|
Emotion Recognition Questionnaire
HC placebo- self-referent
|
15.88 score on a scale
Standard Deviation 6.64
|
18.88 score on a scale
Standard Deviation 3.83
|
|
Emotion Recognition Questionnaire
HC placebo- other-referent
|
16.00 score on a scale
Standard Deviation 6.52
|
17.88 score on a scale
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: At least 45 minutes post nasal spray administrationPopulation: One participant (who received oxytocin first) misunderstood the IQ so was excluded from analysis. One subject who received oxytocin first missed the second placebo drug visit. Another subject who received placebo first accidentally did not receive the Interpretation Questionnaire due to administration error. OCD group was excluded from analysis.
This questionnaire includes 33 ambiguous scenarios, representing 3 conditions: BDD threat scenarios, social anxiety threat scenarios, and general threat scenarios. Each item involves 3 possible thoughts that may come to mind in the scenarios which reflect positive, negative, and neutral interpretations. Participants will be asked to rate the likelihood of having each of the thoughts on a scale of 0 (very unlikely) to 4 (very likely). Total scores are reported for negative threat interpretations for each of the 3 conditions (BDD threat, social anxiety threat, general threat), with scores ranging from 0 (very unlikely) to 44 (very likely).
Outcome measures
| Measure |
Oxytocin, Then Placebo
n=17 Participants
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
n=17 Participants
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
|---|---|---|
|
Interpretation Questionnaire
Oxytocin BDD- BDD threat
|
24.88 score on a scale
Standard Deviation 8.51
|
26.75 score on a scale
Standard Deviation 13.50
|
|
Interpretation Questionnaire
Oxytocin BDD- SA threat
|
27.25 score on a scale
Standard Deviation 4.06
|
33.25 score on a scale
Standard Deviation 16.29
|
|
Interpretation Questionnaire
Oxytocin BDD- Gen threat
|
20.88 score on a scale
Standard Deviation 8.48
|
22.38 score on a scale
Standard Deviation 6.46
|
|
Interpretation Questionnaire
Placebo BDD- BDD threat
|
21.88 score on a scale
Standard Deviation 10.03
|
28.78 score on a scale
Standard Deviation 9.01
|
|
Interpretation Questionnaire
Placebo BDD- SA threat
|
25.75 score on a scale
Standard Deviation 7.76
|
31.11 score on a scale
Standard Deviation 6.37
|
|
Interpretation Questionnaire
Placebo BDD- Gen threat
|
19.88 score on a scale
Standard Deviation 8.13
|
24.33 score on a scale
Standard Deviation 7.86
|
|
Interpretation Questionnaire
Oxytocin HC- BDD threat
|
10.13 score on a scale
Standard Deviation 5.94
|
8.50 score on a scale
Standard Deviation 9.09
|
|
Interpretation Questionnaire
Oxytocin HC- SA threat
|
13.38 score on a scale
Standard Deviation 5.55
|
12.90 score on a scale
Standard Deviation 9.58
|
|
Interpretation Questionnaire
Oxytocin HC- Gen threat
|
16.75 score on a scale
Standard Deviation 6.50
|
15.38 score on a scale
Standard Deviation 9.13
|
|
Interpretation Questionnaire
Placebo HC- BDD threat
|
7.71 score on a scale
Standard Deviation 4.31
|
7.88 score on a scale
Standard Deviation 5.59
|
|
Interpretation Questionnaire
Placebo HC- SA threat
|
15.86 score on a scale
Standard Deviation 5.11
|
12.88 score on a scale
Standard Deviation 7.85
|
|
Interpretation Questionnaire
Placebo HC- Gen threat
|
19.41 score on a scale
Standard Deviation 4.82
|
13.63 score on a scale
Standard Deviation 8.45
|
SECONDARY outcome
Timeframe: At least 45 minutes post nasal spray administrationPopulation: Data reported for BDD and HC participants who completed at least one drug visit. One HC patient in the oxytocin first arm did not complete second placebo visit. Another HC patient in the placebo first arm had missing data from the placebo visit due to administrative error. OCD group was excluded from analyses due to difficulties with recruitment.
The outcome measures are response latencies (in milliseconds) on engagement and disengagement trials for disgust, happy, and neutral cue types. Longer response latencies reflect more sustained attention.
Outcome measures
| Measure |
Oxytocin, Then Placebo
n=16 Participants
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
n=17 Participants
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
|---|---|---|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Oxytocin Neutral Disengagement
|
644.85 milliseconds
Standard Deviation 137.26
|
781.01 milliseconds
Standard Deviation 231.04
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Placebo Disgust Engagement
|
560.64 milliseconds
Standard Deviation 52.51
|
864.02 milliseconds
Standard Deviation 215.64
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Oxytocin Disgust Disengagement
|
613.12 milliseconds
Standard Deviation 72.78
|
834.81 milliseconds
Standard Deviation 219.30
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Oxytocin Disgust Engagement
|
620.73 milliseconds
Standard Deviation 75.60
|
826.90 milliseconds
Standard Deviation 208.97
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Oxytocin Happy Engagement
|
636.56 milliseconds
Standard Deviation 66.07
|
689.32 milliseconds
Standard Deviation 282.68
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Oxytocin Happy Disengagement
|
624.08 milliseconds
Standard Deviation 78.21
|
581.47 milliseconds
Standard Deviation 67.98
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Oxytocin Neutral Disengagement
|
626.80 milliseconds
Standard Deviation 74.58
|
594.96 milliseconds
Standard Deviation 92.18
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Oxytocin Neutral Engagement
|
649.77 milliseconds
Standard Deviation 65.46
|
737.74 milliseconds
Standard Deviation 361.07
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Oxytocin Disgust Disengagement
|
622.30 milliseconds
Standard Deviation 77.45
|
607.09 milliseconds
Standard Deviation 111.39
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Oxytocin Disgust Engagement
|
674.00 milliseconds
Standard Deviation 95.03
|
603.94 milliseconds
Standard Deviation 83.59
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Placebo Happy Engagement
|
587.86 milliseconds
Standard Deviation 57.84
|
718.41 milliseconds
Standard Deviation 401.92
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Placebo Happy Disengagement
|
627.45 milliseconds
Standard Deviation 106.07
|
610.25 milliseconds
Standard Deviation 95.03
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Placebo Neutral Disengagement
|
590.84 milliseconds
Standard Deviation 55.10
|
604.59 milliseconds
Standard Deviation 62.14
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Placebo Neutral Engagement
|
626.99 milliseconds
Standard Deviation 116.93
|
614.46 milliseconds
Standard Deviation 79.94
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Placebo Disgust Disengagement
|
604.24 milliseconds
Standard Deviation 63.82
|
601.19 milliseconds
Standard Deviation 66.31
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
BDD Placebo Disgust Engagement
|
593.57 milliseconds
Standard Deviation 52.72
|
625.31 milliseconds
Standard Deviation 119.00
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Oxytocin Happy Engagement
|
622.08 milliseconds
Standard Deviation 75.20
|
984.01 milliseconds
Standard Deviation 452.85
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Oxytocin Happy Disengagement
|
634.15 milliseconds
Standard Deviation 80.27
|
881.50 milliseconds
Standard Deviation 270.97
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Oxytocin Neutral Engagement
|
656.64 milliseconds
Standard Deviation 120.41
|
871.63 milliseconds
Standard Deviation 336.02
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Placebo Happy Engagement
|
593.97 milliseconds
Standard Deviation 73.17
|
811.25 milliseconds
Standard Deviation 200.97
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Placebo Happy Disengagement
|
576.44 milliseconds
Standard Deviation 78.04
|
919.46 milliseconds
Standard Deviation 268.07
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Placebo Neutral Disengagement
|
575.38 milliseconds
Standard Deviation 108.46
|
774.14 milliseconds
Standard Deviation 150.24
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Placebo Neutral Engagement
|
571.02 milliseconds
Standard Deviation 84.09
|
847.44 milliseconds
Standard Deviation 182.60
|
|
Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task
HC Placebo Disgust Disengagement
|
603.58 milliseconds
Standard Deviation 106.17
|
896.73 milliseconds
Standard Deviation 238.16
|
SECONDARY outcome
Timeframe: At least 45 minutes post nasal spray administrationPopulation: Sample includes BDD and healthy control participants who completed at least one drug visit. OCD group was excluded from analysis due to difficulties with recruitment.
Participants will have the decision of sending between 0 to 10 game dollars to another participant, without any expectation of monetary return. This initial investment amount will serve as a measure of trust, with a transfer of 0 game dollars indicating no trust and a transfer of 10 game dollars indicating maximum trust.
Outcome measures
| Measure |
Oxytocin, Then Placebo
n=17 Participants
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
Placebo, Then Oxytocin
n=17 Participants
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
|
|---|---|---|
|
Amount of Initial Monetary Transfer During Trust Game
Oxytocin BDD- Game 1
|
6.11 units on a scale
Standard Deviation 2.67
|
7.67 units on a scale
Standard Deviation 2.50
|
|
Amount of Initial Monetary Transfer During Trust Game
Placebo BDD- Game 1
|
7.11 units on a scale
Standard Deviation 2.33
|
8.00 units on a scale
Standard Deviation 2.50
|
|
Amount of Initial Monetary Transfer During Trust Game
Oxytocin BDD- Game 2
|
7.22 units on a scale
Standard Deviation 2.33
|
6.89 units on a scale
Standard Deviation 3.51
|
|
Amount of Initial Monetary Transfer During Trust Game
Placebo BDD- Game 2
|
5.22 units on a scale
Standard Deviation 3.35
|
8.00 units on a scale
Standard Deviation 2.50
|
|
Amount of Initial Monetary Transfer During Trust Game
Oxytocin HC- Game 1
|
6.25 units on a scale
Standard Deviation 2.49
|
7.75 units on a scale
Standard Deviation 2.19
|
|
Amount of Initial Monetary Transfer During Trust Game
Placebo HC- Game 1
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7.71 units on a scale
Standard Deviation 2.06
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5.50 units on a scale
Standard Deviation 3.12
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Amount of Initial Monetary Transfer During Trust Game
Oxytocin HC- Game 2
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7.88 units on a scale
Standard Deviation 1.64
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6.88 units on a scale
Standard Deviation 2.75
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Amount of Initial Monetary Transfer During Trust Game
Placebo HC- Game 2
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8.29 units on a scale
Standard Deviation 1.38
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5.50 units on a scale
Standard Deviation 3.12
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Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=34 participants at risk
Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).
Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
|
Placebo
n=33 participants at risk
Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).
Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
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|---|---|---|
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Nervous system disorders
Feeling drowsy or sleepy
|
35.3%
12/34 • Number of events 12 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
33.3%
11/33 • Number of events 11 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Feeling of calmness or euphoria
|
17.6%
6/34 • Number of events 6 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
18.2%
6/33 • Number of events 6 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Difficulty sitting still
|
20.6%
7/34 • Number of events 7 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
21.2%
7/33 • Number of events 7 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Trouble concentrating
|
11.8%
4/34 • Number of events 4 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Blurred vision
|
5.9%
2/34 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
3.0%
1/33 • Number of events 1 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Anxiety or depression
|
8.8%
3/34 • Number of events 3 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Dry mouth/throat
|
5.9%
2/34 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal irritation
|
8.8%
3/34 • Number of events 3 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
0.00%
0/33 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Lightheadedness
|
5.9%
2/34 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Poor memory
|
0.00%
0/34 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
|
Nervous system disorders
Tremors or shakiness
|
0.00%
0/34 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Adverse events data were collected by a nurse using a symptom checklist.
|
Additional Information
Dr. Angela Fang
Massachusetts General Hospital/Harvard Medical School
Phone: 617-643-7717
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place