Clinical trial NCT02191423: Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression
Official title: The Effect of Oxytocin on Brain Attachment and Empathy Networks, and the Association Between the Brain Response and Treatment Outcome of Brief Dyadic Psychotherapy - in Women Suffering From Postpartum Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Keywords: postpartum Depression
Diadic psychotherapy
Oxytocin
fMRI
attachment
empathy
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-07-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rationale and Hypotheses of the Current Research: the investigators speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. While dyadic psychotherapy has been studied in this context, it is unknown which depressed women will respond to this type of therapy, and whether such a response is mediated by the pro-bonding effect of oxytocin.

The aim of this study is three-fold:

1. To study the effect of the administration of a single dose (24IU) of oxytocin on cerebral circuit processing and connectivity of empathy and attachment.
2. To examine whether the clinical response of mothers suffering from postpartum depression to short term dyadic psychotherapy (based on improved mother-child interactions) can be predicted by a unique brain response pattern to oxytocin.
3. To assess the relationship between levels of oxytocin in mother and baby and the effectiveness of psychological dyadic treatment on mothers suffering from postpartum depression.


Eligibility criteria: Inclusion Criteria:

* Women of all ages who are 3 to 8 months post-partum.
* Women who have completed a minimum of 12 years of education.
* Women who are willing and able to provide informed consent for their participation and after the study has been explained. Infant participation will be allowed after consent has been obtained from mothers.
* Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part of the study of protocol number PPD1, proposed to the Helsinki committee on June 2014).
* Symptoms: BDI total score \>9, EPDS total score \>10
* Treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.

Exclusion Criteria:

* Unwilling or unable, in the opinion of the investigator, to comply with study instructions.
* Pregnant women.
* Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
* Women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
* Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
* Women who suffers from depression due to physical condition.
* Women who suffers from severe major depression (MADRAS\>30)
* Women who suffers from chronic depression (over 6 months)

Primary outcomes:
measure: Effect of the administration of oxytocin on cerebral circuit processing
timeFrame: Two functional brain scans one week after admission to the study (week2)
measure: Interactional measures-CIB
timeFrame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
measure: Interactional measures-Noldus
timeFrame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Secondary outcomes:
measure: Maternal depression symptoms measures- BDI
timeFrame: mothers will complete the BDI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
measure: Maternal depression symptoms measures - EPDS
timeFrame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
measure: Maternal anxiety measures-STAI
timeFrame: mothers will complete the STAI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
measure: Physiological measures-Salivary OXT
timeFrame: both mothers and infants will give six saliva samples; once a other week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
measure: Maternal thought and action measures
timeFrame: mothers will complete the YIPTA twice; in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: The Tel-Aviv Sourasky Medical Center
Study officials:
References: