Therapy With an Oxytocin Adjunct for Major Depression

What Was Tested

The trial (phase 2) is built around Oxytocin.

This study evaluates the addition of intranasal oxytocin to the treatment of Major Depression using interpersonal psychotherapy.

Half of the participants will receive a placebo adjunct to interpersonal psychotherapy, and the other half will receive oxytocin.

It had two arms (groups): Placebo Spray And Interpersonal Psychotherapy (placebo comparator) and Oxytocin Spray And Interpersonal Psychotherapy (experimental).

The registry classes the interventions as drug.

More on the Plan

Depression is a debilitating mental health condition that carries great consequences for both the individual and society.

Crucially, at least one third of depressed patients do not respond to existing interventions and relapse rates are high, alerting scientists to the need to explore possible adjunctive treatments and novel therapeutic targets.

It is well documented that interpersonal stress predicts the onset of depression, and that social isolation is a symptom of psychological distress that can leave patients with a poor prognosis for recovery.

Therapeutic interventions focused on the alleviation of social conflict and strengthening of social bonds (i.e.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: visual impairment; acute or chronic nasal diseases or obstruction; current (in the last month) use of any endocrine-relevant or psychotropic medication other than prescription antidepressants.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-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, care provider, investigator and outcomes assessor.

It started in 2015-02 with completion listed for 2016-08.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score] (time frame: Baseline, 4 months later (following therapy)). Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D)[Change Score] (time frame: Baseline, 4 months later (following therapy)). Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score] (time frame: Baseline, 4 months later (following therapy)).

It also tracked 10 secondary outcomes, for example Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score], Biological stress reactivity (Daily Diurnal Cortisol) [Change Score], Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score], Social functioning (patient-rated) (Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS) COMPOSITE SCORE [Change Score], Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score] and Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score].

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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