NCT02405715

Therapy With an Oxytocin Adjunct for Major Depression

Combined Use of Intranasal Oxytocin and Interpersonal Psychotherapy for the Treatment of Major Depressive Disorder (MDD): A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Concordia University, Montreal · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. In this regard, research on the use of oxytocin in the treatment of depression is promising. 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. Interpersonal Psychotherapy; IPT) show greater efficacy for the treatment of depression than other psychological interventions (NIMH Treatment of Depression Collaborative Research Program; Elkin et al. 1984). It has been posited that oxytocin, a naturally produced hormone that is involved in social-support seeking and stress-regulation, could represent a biological link between social stress and depression in adulthood. The salubrious effect of exogenous oxytocin on human social behavior is well documented: Oxytocin has been shown to make individuals feel more securely attached in their social relationships, increase their trust in others and openness to new ideas, improve their recall of specific and positive social autobiographical memories, and improve social learning. Importantly, these factors have been shown to improve the efficacy of Interpersonal Psychotherapy. Thus, It stands to reason that the use of oxytocin as an adjunct to IPT could improve its efficacy for the treatment of depression, which is an important prospect when considering that a third of patients do not respond to existing therapies. In the proposed research project, we will conduct a Randomized Controlled Trial for the treatment of Major Depression with IPT and adjunctive oxytocin. Patients will be screened for eligibility, undergo structured psychotherapy for twelve weeks, and will be followed longitudinally for changes in quality of social functioning, interpersonal stress, psychiatric symptoms and depressive relapse. Establishing novel interventions for depression could position healthcare providers to better alleviate the burden and personal suffering caused by this disorder.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Oxytocin nasal spray or placebo

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-04-01
• Last updated: 2021-07-27

Locations

1 site across 1 country: Canada