Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Postpartum Depression

Treatments: Drug: placebo; Behavioral: Dyadic psychotherapy; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02191423

TASMC-14-MB-161-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

postpartum depression

Experimental group

Description:

Women suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy 1. All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random). 2. All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center. 3. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS \& STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.

Treatment:

Drug: placebo

Behavioral: Dyadic psychotherapy

Drug: Oxytocin

normal controls

Other group

Description:

Normal control women not suffering from postpartum depression assessed by fMRI 1. All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random). 2. A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS \& STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.

Treatment:

Drug: placebo

Drug: Oxytocin