Trial Outcomes & Findings for The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD) (NCT NCT01466127)

Last Updated: 2017-04-14

Results Overview

Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Day 2 of Conditioning (1 day post Day 1 of Conditioning)

Results posted on

2017-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Oxytocin Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Overall Study STARTED	30	30
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	14	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Oxytocin n=14 Participants Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.	Total n=30 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
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.9 Years STANDARD_DEVIATION 14.7 • n=5 Participants	39.9 Years STANDARD_DEVIATION 15.8 • n=7 Participants	35.6 Years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2 of Conditioning (1 day post Day 1 of Conditioning)

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Oxytocin n=14 Participants Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Differential Skin Conductance Response (SCR) During the First Two Extinction Trials	0.15 micro-Siemens (square rooted) Standard Deviation 0.31	0.00 micro-Siemens (square rooted) Standard Deviation 0.39

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

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

Other adverse events
Measure	Placebo n=16 participants at risk Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Oxytocin n=14 participants at risk Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Skin and subcutaneous tissue disorders Bloody Nose	6.2% 1/16 • Number of events 1	0.00% 0/14

Additional Information

Elizabeth Hoge, M.D.

Massachusetts General Hospital

Phone: 617-724-0859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place