Trial Outcomes & Findings for Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety (NCT NCT01551303)

Results Overview

We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so "better" or "worse" outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

30 minutes after drug administration

Results posted on

2014-06-30

Participant Flow

Adults aged 18 to 65 were recruited to the Massachusetts General Hospital through local email and print media advertising from March 2011 to September 2011.

No enrolled participants were excluded before group assignment.

Participant milestones

Participant milestones
Measure	Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal	Placebo Placebo, 0.77 ml, intranasal
Overall Study STARTED	25	22
Overall Study COMPLETED	21	15
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal	Placebo Placebo, 0.77 ml, intranasal
Overall Study failed awareness check on vision test	4	7

Baseline Characteristics

Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=25 Participants Oxytocin, 30 IU in 0.77 ml, intranasal	Placebo n=22 Participants Placebo, 0.77 ml, intranasal	Total n=47 Participants Total of all reporting groups
Age, Continuous	42.24 years STANDARD_DEVIATION 11.61 • n=5 Participants	44.50 years STANDARD_DEVIATION 9.62 • n=7 Participants	43.30 years STANDARD_DEVIATION 10.67 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	22 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after drug administration

We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so "better" or "worse" outcome.

Outcome measures

Outcome measures
Measure	Oxytocin n=25 Participants Oxytocin, 30 IU in 0.77 ml, intranasal	Placebo n=22 Participants Placebo, 0.77 ml, intranasal
Affective Ratings in Affective Learning Task	-0.096 units on a scale Standard Error 0.05	-0.12 units on a scale Standard Error 0.054

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxytocin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=22 participants at risk Matched nasal spray placebo. Placebo: Matched nasal spray placebo	Oxytocin n=25 participants at risk Liquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.
Respiratory, thoracic and mediastinal disorders irritation of nasal passages, temporary	0.00% 0/22	4.0% 1/25 • Number of events 1

Additional Information

Dr. Elizabeth Hoge

Massachusetts General Hospital

Phone: 617-724-0859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place