Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression

NCT ID: NCT02191423

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

postpartum depression

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

administered pre-fMRI assessment

placebo

Intervention Type: DRUG

administered pre-fMRI assessment

Dyadic psychotherapy

Intervention Type: BEHAVIORAL

normal controls

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.

Group Type: OTHER

Oxytocin

Intervention Type: DRUG

administered pre-fMRI assessment

placebo

Intervention Type: DRUG

administered pre-fMRI assessment

Interventions

Oxytocin

administered pre-fMRI assessment

Intervention Type: DRUG

placebo

administered pre-fMRI assessment

Intervention Type: DRUG

Dyadic psychotherapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Syntocinon

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Miki Bloch, Prof.

Role: CONTACT

mikib@tlvmc.gov.il

972-3-6974707

Ruth Feldman, PhD

Role: CONTACT

ortalsh@hotmail.com

972-3-5317943

Other Identifiers

TASMC-14-MB-161-CTIL

Identifier Type: -

Identifier Source: org_study_id