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The Role of Sex Steroids and Serotonin Brain Dynamics in Perinatal Mental Health

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ClinicalTrials.gov Identifier: NCT03795688
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak
Mental Health Centre Copenhagen
University of Copenhagen
Information provided by (Responsible Party):
Vibe G Frøkjær, MD, PhD, Rigshospitalet, Denmark

Brief Summary:

Hormonal transitions such as across pregnancy and postpartum may trigger depressive episodes in some women. It is not known why, but estrogen sensitivity may play a critical role. A preclinical human risk model showed that depressive symptoms induced by pharmacological sex-hormone manipulation is linked to increases in serotonin transporter (SERT) brain binding, which lowers serotonergic brain tone. It is currently unknown if these findings translates to women across pre- to postpartum transitions.

This longitudinal project studies a group of women who will deliver by planned caesarian, thus permitting the collection of cerebrospinal fluid (csf) containing central markers of serotonergic signaling, at the latest point in pregnancy. The women are followed across late pregnancy, delivery and 6 months postpartum to illuminate relations between sex-hormones, stress-regulation, estradiol sensitivity, csf markers of neurotransmission, serotonin transporter genotype variance, and potential development of subclinical or manifest depressive symptoms. Further, markers of relevance for the infant brain development and stress-regulation will be obtained from placenta tissue and umbilical cord blood. A subgroup of 70 women will participate in a brain imaging program early postpartum (week 3-5), which includes an evaluation of brain activity and structure and in vivo molecular brain imaging serotonergic markers. Thus, serotonergic markers in csf can be combined with postpartum molecular brain imaging of key features of serotonin signaling. Women in the imaging program are selected based on variation in their level of mental distress immediately postpartum (day 2-5).

The study's main hypothesis is that women with high-expressing SERT genotypes are more sensitive to peripartum hormonal transition in terms of changes in serotonergic tone and emergence of depressive symptoms and that such an association will be stronger in the presence of candidate gene transcript biomarkers of oestrogen sensitivity. A further hypothesis is that in vivo molecular brain imaging and csf based serotonergic markers will be associated with depressive symptoms both early and later postpartum.

Ideally, this project will provide a rationale for future targeted prevention and/or treatment of perinatal depression in women at high risk, which holds grand potential to protect not only mother but also infant brain health long-term.


Condition or disease Intervention/treatment
Major Depressive Disorder Perinatal Depression Other: Pregnancy

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Role of Sex Steroids and Serotonin Brain Dynamics in Perinatal Mental Health
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
Drug Information available for: Serotonin

Group/Cohort Intervention/treatment
Basic, non-imaging group

Pregnant women who will deliver by planned caesarian. Participants enrolled in the study that are not eligible for the imaging subgroup.

All participants start in the basic program. Includes collection of blood, cerebrospinal fluid, saliva, hair, placenta tissues, umbilical cord blood and psychometrics.

Other: Pregnancy
Peripartum transition from pregnant to postpartum state

Extended, imaging group
A subgroup of 70 pregnant women who will deliver by planned caesarian selected towards either high (N=35) or low (N=35) risk for perinatal depression will undergo brain imaging in addition to the elements of the basic program. The extended imaging program includes functional and structural magnetic resonance imaging, positron emission tomography (PET) and a semistructured interview for depression symptoms (HAM-D17).
Other: Pregnancy
Peripartum transition from pregnant to postpartum state




Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Week 3-6 postpartum ]
    Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Total group

  2. Depressive symptoms [ Time Frame: Week 3-6 postpartum ]
    Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group

  3. Gene transcript and DNA methylation markers of estrogen sensitivity [ Time Frame: Prior to caesarean section ]

    116 a priori defined gene transcripts, which where differentially expressed in third trimester of women who later developed perinatal depression with postpartum onset relative to pregnant women who did not and to other depressed (reference Mehta et al, 2014, Psychological Medicine) and confirmed to be coupled to estrogen fluctuations (Mehtaet al. 2018 British Journal of Psychiatry) will be evaluated in the total group.

    Also DNA methylation of the genes of these transcripts will be determined and analysed in terms of their predictive value (above chance) for perinatal depression.


  4. Cerebral serotonin 4 receptor binding postpartum [ Time Frame: Week 3-6 postpartum ]
    Latent variable construct of brain 5-HT4R level based on quantification of 5-HT4R binding from 11C-SB207145 positron emission tomography in primary volumes of interest; neocortex, nucleus caudatus, putamen and hippocampus. Assessed in imaging group.

  5. CSF levels of GABA [ Time Frame: On day of caesarean section ]
    Assessed in total group

  6. CSF levels of serotonin metabolite (5-HIAA) [ Time Frame: On day of caesarean section ]
    Assessed in total group

  7. Cortisol awakening response [ Time Frame: Week 3-6 postpartum ]
    Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening.

  8. Hair cortisol level mothers [ Time Frame: On day of caesarean section. ]
    Provides an estimate of cortisol exposure up to 6 months prior to delivery, total group

  9. Hair cortisol level newborns [ Time Frame: Day 0-5 postpartum. ]
    Provides an estimate of fetal cortisol exposure, infants from total group

  10. Hippocampal volumes [ Time Frame: Week 3-6 postpartum. ]
    Hippocampal brain volume (including hippocampus) from structural MRI, imaging group.

  11. functional MRI response to reward [ Time Frame: Week 3-6 postpartum. ]
    fMRI (BOLD response) based assessment of brain activity in response to reward, relative to non-reward, stimuli. Assessed in imaging cohort

  12. Resting state functional connectivity MRI [ Time Frame: Week 3-6 postpartum ]
    rsfMRI based spontaneous co-fluctuations in low frequency BOLD signal, (functional connectivity). Assessed with rsfMRI scan in the resting state, i.e. non-goal oriented spontaneous thought and awake. Assessed in imaging group.

  13. Change in epigenetic SERT status [ Time Frame: From just before delivery to 3-6 weeks postpartum ]
    Change in epigenetic SERT status from late pregnancy to postpartum week 3-6.

  14. Concentration of inflammatory markers, i.e hsCRP and immunoactive cytokines, in peripheral blood [ Time Frame: At week 3-6 ]
    Composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group

  15. functional MRI response to emotional faces [ Time Frame: Week 3-6 postpartum. ]
    fMRI (BOLD response) based assessment of brain activity to emotionally salient, relative to neutral, stimuli. Assessed in imaging cohort.


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Day 3-5 postpartum ]
    Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group

  2. Depressive symptoms [ Time Frame: Week 12 postpartum ]
    Score on the Hamilton 17-item depression scale. Score range: 0-52. Higher scores indicate more depressive symptoms. Assessed in imaging group

  3. Depressive symptoms [ Time Frame: Day 3-5 postpartum ]
    Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Assessed in total group

  4. Depressive symptoms [ Time Frame: 6 months postpartum ]
    Edinburgh Postnatal Depression Scale. Score range: 0-30. Higher scores indicate more symptoms of postpartum depression. Assessed in all

  5. CSF levels of serotonin [ Time Frame: On day of caesarean section ]
    Assessed in total group

  6. CSF levels of dopamine metabolites [ Time Frame: On day of caesarean section ]
    Assessed in total group

  7. CSF levels of noradrenaline metabolites [ Time Frame: On day of caesarean section ]
    Assessed in total group

  8. CSF levels of inflammatory markers [ Time Frame: On day of caesarean section ]
    Composite measure of IFN-c, IFN-alfa TNF-alfa og IL-6, in total group

  9. Estradiol level [ Time Frame: Prior to caesarean section. ]
    Estradiol level in peripheral blood, total group

  10. Estradiol level [ Time Frame: At week 3-6 postpartum. ]
    Estradiol level peripheral blood, total group

  11. Change in estradiol level [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Estradiol change pre- to postpartum, peripheral blood total group

  12. Progesterone level [ Time Frame: Prior to caesarean section. ]
    Progesterone level in peripheral blood

  13. Progesterone level [ Time Frame: At week 3-6 postpartum. ]
    Progesterone level in peripheral blood

  14. Change in progesterone level [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Progesterone change pre- to postpartum, peripheral blood total group

  15. Allopregnanolone level [ Time Frame: Prior to caesarean section. ]
    Allopregnanolone level in peripheral blood

  16. Allopregnanolone level [ Time Frame: At week 3-6 postpartum. ]
    Allopregnanolone level in peripheral blood

  17. Change in allopregnanolone level [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change in allopregnanolone level in peripheral blood

  18. Change in cortisol level [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Cortisol change pre- to postpartum, peripheral blood total group

  19. Cortisol awakening response [ Time Frame: Week 12 postpartum ]
    Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening.

  20. Cortisol awakening response [ Time Frame: Prior to caesarean section ]
    Cortisol awakening response, area under the curve with respect to baseline from 0 to 60 minutes from awakening.

  21. Change in cortisol awakening response [ Time Frame: ´From baseline (caesarean section to week 3-6 postpartum) ]
    Change in cortisol awakening response, from caesarean section to 3-6 weeks postpartum.

  22. DNA methylation of the SERT gene [ Time Frame: Prior to caesarean section ]
    Methylation status for the SERT gene, total group

  23. DNA methylation of the SERT gene [ Time Frame: Week 3-6 postpartum ]
    DNA Methylation status for the SERT gene, total group

  24. DNA methylation of the FK506-binding protein 51 (FKBP5) gene [ Time Frame: Prior to caesarean section. ]
    Methylation status for the FK506-binding protein 51 (FKBP5) gene, total group

  25. DNA methylation of the FK506-binding protein 51 (FKBP5) gene [ Time Frame: Week 3-6 postpartum ]
    Methylation status for the FK506-binding protein 51 (FKBP5) gene, total group

  26. Change in DNA methylation of the FK506-binding protein 51 (FKBP5) gene [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change in methylation status for the FK506-binding protein 51 (FKBP5) gene from late pregnancy to postpartum week 3-6.

  27. DNA methylation of the glucocorticoid receptor gene [ Time Frame: Prior to caesarean section. ]
    Methylation status for the glucocorticoid receptor gene, total group

  28. DNA methylation of the glucocorticoid receptor gene [ Time Frame: Week 3-6 postpartum ]
    Methylation status for the glucocorticoid receptor gene, total group

  29. Change in DNA methylation of the glucocorticoid receptor gene [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change in methylation status for the glucocorticoid receptor gene from late pregnancy to postpartum week 3-6.

  30. DNA methylation of the COMT gene [ Time Frame: Prior to caesarean section. ]
    Methylation status for the COMT gene, total group

  31. DNA methylation of the COMT gene [ Time Frame: Week 3-6 postpartum ]
    Methylation status for the COMT gene, total group

  32. Change in DNA methylation of the COMT gene [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change in methylation status for the COMT gene from just before delivery to 3-6 weeks postpartum

  33. DNA methylation of the MAO-A gene [ Time Frame: Prior to caesarean section. ]
    Methylation status for the MAO-A gene, total group

  34. Change in DNA methylation of the MAO-A gene [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change in methylation status for the MAO-A gene, total group

  35. DNA methylation of the MAO-A gene [ Time Frame: Week 3-6 postpartum ]
    Methylation status for the MAO-A gene, total group

  36. DNA methylation of the oxytocin receptor gene [ Time Frame: Prior to caesarean section. ]
    Methylation status for the oxytocin receptor gene, total group

  37. DNA methylation of the oxytocin receptor gene [ Time Frame: Week 3-6 postpartum ]
    Methylation status for the oxytocin receptor gene, total group

  38. Change in DNA methylation of the oxytocin receptor gene [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change in methylation status for the oxytocin receptor gene, total group

  39. DNA methylation of the oxytocin gene [ Time Frame: Prior to caesarean section. ]
    Methylation status for the oxytocin gene, total group

  40. DNA methylation of the oxytocin gene [ Time Frame: Week 3-6 postpartum ]
    Methylation status for the oxytocin gene, total group

  41. Change in DNA methylation of the oxytocin gene [ Time Frame: From baseline (caesarean section to week 3-6 postpartum) ]
    Change methylation status for the oxytocin gene, total group

  42. Systemic inflammation peripheral blood hsCRP and immunoactive cytokines [ Time Frame: Prior to caesarean section. ]
    Composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group

  43. Change in systemic inflammation peripheral blood hsCRP and immunoactive cytokines [ Time Frame: From baseline (caesarean section to week 3-6 postpartum ]
    Change in composite measure of hsCRP, TNF-α, IL-6, IL-18 and IL-10 levels, total group

  44. Self reported family history of mood disorders [ Time Frame: Day 3-5 postpartum or before ]
    Family History Assessment Module (OS-FHAM). Number of first degree relatives with a history of depressive episodes or bipolar disorder. Total group.

  45. Self reported impulsiveness score [ Time Frame: Day 3-5 postpartum or before ]
    Barratt Impulsiveness Scale (BIS-11), self-reported. Range: 30-120. Total group.

  46. Self reported Neuroticism score from NEO personality questionnaire [ Time Frame: Day 3-5 postpartum or before ]
    NEO-PI-R - Revised NEO Personality Inventory, self-reported. Participants may score 20-80 for each of the personality traits: openness, conscientiousness, extraversion, agreeableness, and neuroticism. The higher the score, the more prominent is the personality trait. Total group.

  47. Self reported parental bonding quality [ Time Frame: Day 3-5 postpartum or before ]
    Parental bonding instrument (PBI), both parents, self-reported. Total group.

  48. Self-reported perceived stress [ Time Frame: Day 3-5 postpartum ]
    Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group.

  49. Self-reported perceived stress [ Time Frame: Week 3-6 postpartum ]
    Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group.

  50. Change in self-reported perceived stress [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Perceived Stress Scale (PSS), range 0-40, a score of 0 indicates no perceived stress. Total group.

  51. Self-reported anhedonia [ Time Frame: Day 3-5 postpartum ]
    Snaith-Hamilton Pleasure Scale (SHAPS), range 0-14, a score of 0 indicates no self-reported anhedonia. Total group.

  52. Self-reported anhedonia [ Time Frame: Week 3-6 postpartum ]
    Snaith-Hamilton Pleasure Scale (SHAPS), range 0-14, a score of 0 indicates no self-reported anhedonia. Total group.

  53. Change in self-reported anhedonia [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Snaith-Hamilton Pleasure Scale (SHAPS) score, range 0-14, a score of 0 indicates no self-reported anhedonia. Total group.

  54. Self-reported rumination [ Time Frame: Day 3-5 postpartum ]
    Rumination Response Scale (RRS), range 22-88, a score of 22 indicates no ruminative symptoms. Total group.

  55. Self-reported rumination [ Time Frame: Week 3-6 postpartum ]
    Rumination Response Scale (RRS), range 22-88, a score of 22 indicates no ruminative symptoms. Total group.

  56. Change in elf-reported rumination [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Rumination Response Scale (RRS) score, range 22-88, a score of 22 indicates no ruminative symptoms. Total group.

  57. Self-reported mood [ Time Frame: Day 3-5 postpartum ]
    Profile of Mood States (POMS), range 0-260, a score of 0 indicates no mood disturbance. Total group.

  58. Self-reported mood [ Time Frame: Week 3-6 postpartum ]
    Profile of Mood States (POMS), range 0-260, a score of 0 indicates no mood disturbance. Total group.

  59. Change in self-reported mood [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Profile of Mood States (POMS) score, range 0-260, a score of 0 indicates no mood disturbance. Total group.

  60. Self-reported sleep quality [ Time Frame: Day 3-5 postpartum ]
    Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group.

  61. Self-reported sleep quality [ Time Frame: Week 3-6 postpartum ]
    Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group.

  62. Change in self-reported sleep quality [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Pittsburgh Sleep Quality Index (PSQI), range 0-21, a score of 0 indicates a healthy sleep quality. Total group.

  63. Self-reported psychiatric symptoms [ Time Frame: Day 3-5 postpartum ]
    Brief symptom Inventory-53 item (BSI-53), range 0-212, increasing score means worsening of symptoms.Total group.

  64. Self-reported psychiatric symptoms [ Time Frame: Week 3-6 postpartum ]
    Brief symptom Inventory-53 item (BSI-53), range 0-212, increasing score means worsening of symptoms.Total group.

  65. Change in self-reported psychiatric symptoms [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Brief symptom Inventory-53 item (BSI-53) score, range 0-212, increasing score means worsening of symptoms.Total group.

  66. Self-reported well-being [ Time Frame: Day 3-5 postpartum ]
    WHO-5 well-being index, range 0-100, low score means less well-being. Total group.

  67. Self-reported well-being [ Time Frame: Week 3-6 postpartum ]
    WHO-5 well-being index, range 0-100, low score means less well-being. Total group.

  68. Change in self-reported well-being [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in WHO-5 well-being index, range 0-100, low score means less well-being. Total group.

  69. Self-reported anxiety [ Time Frame: Day 3-5 postpartum ]
    State Trait Anxiety Inventory (STAI-AD-D), state and trait subscales each have a range of 20-80, 20 means no anxiety. Total group.

  70. Self-reported anxiety [ Time Frame: Week 3-6 postpartum ]
    State Trait Anxiety Inventory (STAI-AD-D), state subscale range 20-80, 20 means no anxiety. Total group.

  71. Change in self-reported anxiety [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in State Trait Anxiety Inventory (STAI-AD-D) score, state subscale range 20-80, 20 means no anxiety. Total group.

  72. Self-reported obsessive and compulsive symptoms [ Time Frame: Day 3-5 ]
    Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group.

  73. Self-reported obsessive and compulsive symptoms [ Time Frame: Week 3-6 postpartum ]
    Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group.

  74. Change in self-reported obsessive and compulsive symptoms [ Time Frame: Change from day 3-5 to week 3-6 postpartum ]
    Change in Obsessive-Compulsive Inventory (OCI) score, self-reported, range 0-72, higher scores indicate more symptoms. Total group.

  75. Performance on Simple Reaction Time [ Time Frame: Week 3-6 postpartum ]
    Performance on Simple Reaction Time, in imaging cohort.

  76. Gray matter brain volume prefrontal cortex and anterior cingulate cortex [ Time Frame: At week 3-6 postpartum ]
    Gray matter brain volume prefrontal cortex and anterior cingulate cortex

  77. Serotonergic turnover in placenta [ Time Frame: At delivery. ]
    Composite measure of serotonin, tryptophan og tryptofan hydroxylase levels relative to 5-HIAA, in placenta sample. Infants from total group

  78. 11-beta-hydroxysteroid dehydrogenase type 2 activity in placenta [ Time Frame: At delivery ]
    11-beta-hydroxysteroid dehydrogenase type 2 activity in placenta. Infants from total group

  79. Methylation status of genes relevant for stress-hormone regulation in placenta [ Time Frame: At delivery ]
    Composite measure of methylation status for the FKBP5, glucocorticoid receptor, 11-beta hydroxysteroid dehydrogenase type 2 genes. Infants from total group

  80. Methylation status of genes related to serotonergic signaling in placenta [ Time Frame: At delivery ]
    Composite measure of the methylation status for monoamine oxidase, serotonin receptor and serotonin transporter genes. Infants from total group

  81. Methylation status and gene transcript profiles of relevance for early brain development and stress regulation in newborn infants [ Time Frame: At delivery. ]
    Composite measure of methylation status and gene transcript profiles of Glucocorticoid receptor, FKBP5, oxytocin and oxytocin receptors, Brain-derived neurotrophic factor (BDNF) genes. Assessed in blood from umbilical cord blood sample from infants, total group.


Other Outcome Measures:
  1. COMT-genotype (rs4680) variant, i.e met/met vs other polymorphisms [ Time Frame: Prior to caesarean section. ]
    val158met (rs4680) status, binary variable, i.e. "val/val, val/met" vs "met/met" variants

  2. BDNF genotype (rs6265) status, i.e. val/val versus met-carrier variants [ Time Frame: Prior to caesarean section. ]
    BDNF val66met (rs6265) status, binary variable, i.e. "val/val" versus "met-carrier" status

  3. 5-HTT genotype status, i.e LALA vs low-expressing (S or LG) variants [ Time Frame: Prior to caesarean section. ]
    5-HTTLPR genotype status (binary), i.e. high-expressing LALA vs low-expressing (S or LG) variants, based on SLC6A4, i.e. L or S variants, and further subtyping on rs25531 haplotype L(A)L(A) vs LGLA, LGLG or variants containing as S as specified above.

  4. Postpartum blues symptoms [ Time Frame: Day 3-5 postpartum. ]
    In house interview based on Kennerley Maternity Blues Questionnaire, range: 0-28, higher score indicates more severe postpartum blues symptoms. High blues score is associated with greater risk for perinatal depression at week 3-6.

  5. Postpartum blues symptoms [ Time Frame: Day 3-5 postpartum. ]
    In house interview based on Stein's Maternity Blues Scale, range 0-26. High blues score is associated with greater risk for perinatal depression at week 3-6.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from the midwife clinic at Rigshospitalet, Copenhagen, i.e., included women will be residents of the central Copenhagen area.
Criteria

Inclusion Criteria:

  • Age 18-40 years
  • Healthy pregnant women planned to deliver by caesarean section due to breech position of the fetus or previous caesarean section.

Exclusion Criteria:

  • Current or previous severe psychiatric disorder such as psychotic disorders, eating disorder and bipolar disorder or current or previous psychiatric disorder requiring hospitalization.
  • Current or previous neurological diseases, severe somatic disease, severe postpartum hemorrhage or use of medication that can interfere with study outcomes
  • Severe disease or malformations in infants
  • Obesity or underweight (pre-gestational BMI below 18 or above 35)
  • Not fluent in Danish or severe visual or hearing impairments
  • Earlier or present learning disabilities
  • MRI contraindications (claustrophobia, metal implants)
  • Previous exposure to radioactivity > 10 millisievert (mSv) within the last year
  • Alcohol or drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795688


Contacts
Layout table for location contacts
Contact: Vibe Frokjaer, MD, PhD +45 35456714 vibe@nru.dk
Contact: Camilla Larsen, MD +35456712 camilla.borgsted.larsen@nru.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Vibe Frøkjær, MD, PhD    +4535456714    vibe@nru.dk   
Sponsors and Collaborators
Vibe G Frøkjær, MD, PhD
Center for Integrated Molecular Brain Imaging, Copenhagen, Denmak
Mental Health Centre Copenhagen
University of Copenhagen
Investigators
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Principal Investigator: Vibe Frokjaer, MD, PhD Rigshospitalet, Denmark

Additional Information:

Publications:

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Responsible Party: Vibe G Frøkjær, MD, PhD, Senior researcher, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03795688     History of Changes
Other Study ID Numbers: PND1
H-18029563 ( Other Identifier: Regional ethics committee )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via database of Center for Integrated Molecular Brain Imaging (Knudsen et al 2016, NeuroImage) data will be available for neuroscience research community contingent on approval by scientific board.
Supporting Materials: Study Protocol
Time Frame: 2020-2035
Access Criteria: Approval by scientific board

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs