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This research study will look at brain and symptom differences among women with severe premenstrual mood symptoms. One goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The investigators will also look at whether oxytocin improves premenstrual mood symptoms.
Purpose: The primary objective of this pilot study is to use functional neuroimaging techniques to begin to identify the central brain networks that may contribute to impairment in emotion regulation, interpersonal relationships, and marital and family function in women with premenstrual dysphoric disorder (PMDD), particularly for those women who also have a history of early life abuse (ELA).
Based on the evidence that the mammalian neuropeptide oxytocin (OT), best known for its role in lactation and parturition, plays a seminal role in social affiliation, emotion regulation, attachment, maternal behavior, trust, and protection against stress; and because OT neural pathways and receptors are prominently expressed in brain regions involved in emotion regulation and maternal/affiliative behavior; the study will: 1) use intranasal OT administration as a probe to assess whether it modifies activation of brain regions involved in emotion regulation in response to an emotional processing task; and 2) whether daily intranasal OT administration during the premenstrual phase improves symptoms in women with PMDD with or without a history of ELA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin, then Placebo | Experimental | 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 | Experimental | Participants were randomized to receive Intranasal Placebo for late luteal phase administration during one menstrual cycle, then received Intransal 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Intranasal Oxytocin spray (40 IU, 3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Premenstrual Symptom Severity | 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. | During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment) |
| Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI) | 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. | 1 hour of scanning during the late luteal phase of two consecutive menstrual cycles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Girdler, PH.D. | UNC-Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27517 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Within-person experimental design, each participant received oxytocin and placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin, Then Placebo | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Premenstrual Symptom Severity | 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. | Posted | Mean | Standard Deviation | units on a scale | During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment | Mild headache reported by two participants during oxytocin administration. |
Results of this study should be interpreted with caution due to the small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Girdler | University of North Carolina at Chapel Hill | 919-966-2179 | susan_girdler@med.unc.edu |
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Intranasal Placebo spray (3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins |
|
| BG001 |
| Placebo, Then Oxytocin |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Oxytocin |
Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days |
| OG001 | Placebo | Intranasal Placebo spray (3x/day) for 4-5 days |
|
|
| Primary | Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI) | 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. | Posted | Mean | Standard Deviation | parameter estimate | 1 hour of scanning during the late luteal phase of two consecutive menstrual cycles |
|
|
|
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Placebo | Intranasal Placebo spray (3x/day) for 4-5 days | 0 | 10 | 0 | 10 | 1 | 10 |
|
| Uterine cramps | Reproductive system and breast disorders | Systematic Assessment | Mild uterine cramping reported by two participants during oxytocin administration. |
|
| Clogged nostril | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Participant reported one nostril became slightly clogged during intranasal Placebo administration. |
|
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |