Trial Outcomes & Findings for Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study (NCT NCT02508103)

Last Updated: 2017-06-27

Results Overview

The investigators will analyze premenstrual symptom severity ratings during the late luteal phase of two consecutive menstrual cycles to assess the effects of intranasal oxytocin (vs. placebo) on premenstrual symptom severity. Daily premenstrual symptoms were measured using the Daily Record of Severity of Problems (DRSP; Endicott et al., 2006). Across 24 items representing emotional, physical, and behavioral symptoms, participants indicated "the degree to which the problems have been experienced today": 1-Not at all, 2-Minimal, 3-Mild, 4-Moderate, 5-Severe, or 6-Extreme. For each participant, we calculated a total score by summing all 24 items. We then calculated a mean total score for each condition by averaging all participants total scores in a given condition. Higher scores represent greater symptoms. Range of total score is 24 to 144.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

10 participants

Primary outcome timeframe

During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)

Results posted on

2017-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin, Then Placebo Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Placebo for late luteal phase administration of a subsequent menstrual cycle. Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days	Placebo, Then Oxytocin Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Oxytocin for late luteal phase administration of a subsequent menstrual cycle. Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin, Then Placebo n=5 Participants Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Intranasal Placebo for late luteal phase administration of a subsequent menstrual cycle. Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days	Placebo, Then Oxytocin n=5 Participants Participants were randomized to receive Intransal Placebo for late luteal phase administration during one menstrual cycle, then received Intranasal Oxytocin for late luteal phase administration of a subsequent menstrual cycle. Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days	Total n=10 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 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	36.4 years n=5 Participants	36.8 years n=7 Participants	36.6 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)

Outcome measures

Outcome measures
Measure	Oxytocin n=10 Participants Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days	Placebo n=10 Participants Intranasal Placebo spray (3x/day) for 4-5 days
Change in Premenstrual Symptom Severity	25.05 units on a scale Standard Deviation 16.74	27.36 units on a scale Standard Deviation 13.80

PRIMARY outcome

Timeframe: 1 hour of scanning during the late luteal phase of two consecutive menstrual cycles

During fMRI scanning, the investigators will assess the effects of intranasal oxytocin (vs. placebo) on amygdala response to cognitive-emotional processing task (Hariri et al., 2006) during the late luteal phase of two consecutive menstrual cycles. Amygdala reactivity was assessed by extracting a "contrast of parameter estimate" (COPE) for each region (left and right amygdala). Regions were defined using binarized Harvard-Oxford Subcortical Atlas masks. The parameter estimate was the average estimate of all voxels in each region for the task contrast of viewing Faces vs. Shapes. We used neuroimaging software package FSL to calculate and extract these parameter estimates.

Outcome measures

Outcome measures
Measure	Oxytocin n=10 Participants Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days	Placebo n=10 Participants Intranasal Placebo spray (3x/day) for 4-5 days
Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI) Right Amygdala	1.14 parameter estimate Standard Deviation 0.57	1.22 parameter estimate Standard Deviation 1.25
Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI) Left Amygdala	0.89 parameter estimate Standard Deviation 0.48	0.95 parameter estimate Standard Deviation 0.81

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

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	Oxytocin n=10 participants at risk Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days	Placebo n=10 participants at risk Intranasal Placebo spray (3x/day) for 4-5 days
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos). For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.	0.00% 0/10 • Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos). For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.
Reproductive system and breast disorders Uterine cramps	20.0% 2/10 • Number of events 2 • Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos). For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.	0.00% 0/10 • Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos). For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.
Respiratory, thoracic and mediastinal disorders Clogged nostril	0.00% 0/10 • Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos). For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.	10.0% 1/10 • Number of events 1 • Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos). For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.

Additional Information

Dr. Susan Girdler

University of North Carolina at Chapel Hill

Phone: 919-966-2179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place