Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression

What Was Tested

This registered not phased trial tested Oxytocin.

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.

The aim of this study is three-fold: 1.

It had two arms (groups): postpartum depression (experimental) and normal controls (other).

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women of all ages who are 3 to 8 months post-partum. Women who have completed a minimum of 12 years of education. 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.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: unwilling or unable, in the opinion of the investigator, to comply with study instructions; pregnant women; women who suffers from depression due to physical condition.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2015-01 with completion listed for 2016-06.

It ran at 1 site in Israel.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Effect of the administration of oxytocin on cerebral circuit processing (time frame: Two functional brain scans one week after admission to the study (week2)). Interactional measures-CIB (time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year). Interactional measures-Noldus (time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year).

It also tracked 5 secondary outcomes, for example Maternal depression symptoms measures- BDI, Maternal depression symptoms measures - EPDS, Maternal anxiety measures-STAI, Physiological measures-Salivary OXT and Maternal thought and action measures.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.