- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762943
Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7175
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Group 1: Women with a history of PPD
- A history of a major depression episode that occurred within two months of childbirth (as determined by a SCID interview) and remitted at least one year prior to enrollment in the study;
- has been well for a minimum of one year;
- a regular menstrual cycle for at least three months;
- age 22-50;
- not pregnant, not lactating and in good medical health;
- medication free (not including birth control pills; participants may opt to temporarily discontinue birth control pills to participate);
- no history of puerperal suicide attempts or psychotic episodes requiring hospitalization.
Group 2: Healthy Controls
1) Controls will meet all inclusion criteria specified above except they must not have any past or present Axis I diagnosis or evidence of menstrually related mood disorders.
A structured clinical interview (SCID) will be administered to all women prior to study entry. Any woman with a current axis I psychiatric diagnosis will be excluded from participating in this protocol.
Exclusion Criteria:
Patients will not be permitted to enter this protocol if they have important clinical or laboratory abnormalities including any of the following:
- current axis I psychiatric diagnosis
- endometriosis;
- undiagnosed enlargement of the ovaries;
- liver disease;
- breast cancer;
- a history of blood clots in the legs or lungs;
- undiagnosed vaginal bleeding;
- porphyria;
- diabetes mellitus;
- malignant melanoma;
- gallbladder or pancreatic disease;
- heart or kidney disease;
- cerebrovascular disease (stroke);
- cigarette smoking;
- a history of suicide attempts or psychotic episodes requiring hospitalization;
- recurrent migraine headaches;
- pregnancy (patients will be warned not to become pregnant during the study and will be required to agree to employ barrier contraceptive methods);
- pregnancy-related medical conditions such as hyperemesis, pre-toxemia and toxemia, deep vein thrombosis (DVT) and bleeding diathesis;
Any woman with a first degree relative (immediate family) with either ovarian cancer, premenopausal breast cancer or breast cancer presenting in both breasts or any woman who has multiple family members (greater than three relatives) with postmenopausal breast cancer will also be excluded from participating in this protocol;
Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for perimenopause will be excluded from participation. Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (> 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women with Postpartum Depression (PPD)
4 monthly (intramuscular) IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.
Participants will also receive placebo.
|
All subjects will receive one IM injection (3.75 mg) each month for four months.
Other Names:
All participants will receive micronized estradiol daily for eight weeks.
Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.
Other Names:
All subjects will receive micronized progesterone daily for eight weeks.
Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.
Other Names:
|
Experimental: Women without any psychiatric history (Control)
4 monthly (intramuscular) IM injections of leuprolide acetate (Lupron) 3.75 mg; micronized estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day; progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.
Participants will also receive placebo.
|
All subjects will receive one IM injection (3.75 mg) each month for four months.
Other Names:
All participants will receive micronized estradiol daily for eight weeks.
Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.
Other Names:
All subjects will receive micronized progesterone daily for eight weeks.
Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic
Time Frame: baseline and hormone withdrawal
|
The primary outcome measure was functional magnetic resonance imaging (fMRI) data collected during a Monetary Incentive Delay (MID) Task.
The BOLD response was examined within the nucleus accumbens, a brain region that responds to monetary rewards.
The z statistic represents the maximum contrast between win versus non-win outcomes during the MID task in the nucleus accumbens, averaged across the participants in each group.
The mean BOLD response ranged from z=1.7 to 2.3; higher z scores indicate greater activation of the nucleus accumbens during reward.
Individual z scores were generated using the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library (FSL), which is a library of brain imaging analysis tools for fMRI.
|
baseline and hormone withdrawal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Score
Time Frame: Assessed at baseline and post-treatment
|
The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating "not at all" and 5 indicating "extremely".
As such, the range of possible scores is 10 to 50.
The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry.
Higher scores indicate greater dysphoria.
|
Assessed at baseline and post-treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Crystal E Schiller, Ph.D., University of North Carolina, Chapel Hill
- Principal Investigator: David R Rubinow, M.D., University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- Depression, Postpartum
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Progestins
- Leuprolide
- Estradiol
- Progesterone
Other Study ID Numbers
- 12-1758
- 5R21MH101409 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on Leuprolide Acetate
-
AbbottCompletedPuberty, PrecociousUnited States, Puerto Rico
-
Camurus ABCompletedPhase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate CancerProstate CancerFinland, Hungary
-
University of UtahUniversity of Chicago; University of MichiganCompletedPrecocious Puberty | Delayed PubertyUnited States
-
AbbottFraktal.com.pl; Med-net.plCompletedLower Urinary Tract Symptoms | Advanced Prostate CancerPoland, Ukraine
-
Urology of VirginiaFerring PharmaceuticalsCompletedProstate CancerUnited States
-
M.D. Anderson Cancer CenterTAP Pharmaceutical Products Inc.CompletedAmenorrhea | Premature Ovarian Failure | Ovarian Function InsufficiencyUnited States
-
University Magna GraeciaUnknown
-
SOTIO a.s.CompletedProstate CancerCzechia
-
San Bernardino Urological Associates Medical Group...Completed
-
GP-PharmCompletedProstate CancerUnited States, Austria, Czech Republic, Germany, Hungary, Italy, Slovakia, Spain, United Kingdom