Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression

NCT02191423 | Unknown DMC

• 1 other identifier: TASMC-14-MB-161-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Keywords

postpartum Depression; Diadic psychotherapy; Oxytocin; fMRI; attachment; empathy

Outcome Measures

Primary Outcomes (3)

• Effect of the administration of oxytocin on cerebral circuit processing

  1\. This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. "this person just won the lottery"). Control condition presents participants with images of people performing everyday actions. 3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer. 2\. This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.

  Two functional brain scans one week after admission to the study (week2)

• Interactional measures-CIB

  The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship

  pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year

• Interactional measures-Noldus

  Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.

  pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year

Secondary Outcomes (5)

• Maternal depression symptoms measures- BDI

  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

• Maternal depression symptoms measures - EPDS

  pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year

• Maternal anxiety measures-STAI

  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

• Physiological measures-Salivary OXT

  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

• Maternal thought and action measures

  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

Study Arms (2)

postpartum depression

EXPERIMENTAL

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.

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

normal controls

OTHER

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.

Drug: Oxytocin; Drug: placebo

Interventions

Oxytocin DRUG

administered pre-fMRI assessment

Also known as: Syntocinon

normal controls; postpartum depression

placebo DRUG

administered pre-fMRI assessment

normal controls; postpartum depression

Dyadic psychotherapy BEHAVIORAL

postpartum depression

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

The Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Miki Bloch, Prof.

CONTACT

972-3-6974707; mikib@tlvmc.gov.il

Ruth Feldman, PhD

CONTACT

972-3-5317943; ortalsh@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 16, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

IL (1)