Therapy With an Oxytocin Adjunct for Major Depression

NCT ID: NCT02405715

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Spray And Interpersonal Psychotherapy

Participants will receive 6 sprays of a placebo nasal spray prior to the beginning of each session of interpersonal psychotherapy (16 sessions in total).

Group Type: PLACEBO_COMPARATOR

Oxytocin nasal spray or placebo

Intervention Type: DRUG

Oxytocin Spray And Interpersonal Psychotherapy

Participants will receive 6 sprays of a oxytocin nasal spray prior to the beginning of each session of interpersonal psychotherapy (16 sessions in total). Each spray will contain 4IU of oxytocin, for a total dose of 24IU.

Group Type: EXPERIMENTAL

Oxytocin nasal spray or placebo

Intervention Type: DRUG

Interventions

Oxytocin nasal spray or placebo

Intervention Type: DRUG

Other Intervention Names

Syntocinon

Eligibility Criteria

Inclusion Criteria

• Current Major Depressive Episode

Exclusion Criteria

• Visual impairment
• Major medical illness [A condition that is chronic and associated with impaired functioning, distress, or frequent medical intervention), in particular, subjects with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease
• Acute or chronic nasal diseases or obstruction
• Current (in the last month) use of any endocrine-relevant or psychotropic medication other than prescription antidepressants
• Current substance dependence or abuse
• Use of illicit drugs (stimulants, narcotics, psychedelics/hallucinogens, non-prescription medication) in the past 8 weeks
• Lifetime history of a psychosis (except if part of MDD) or pervasive developmental disorder
• Past or current comorbid axis-1 disorder except Dysthymia, Adjustment Disorder, Generalized Anxiety Disorder, Social Phobia, and Specific Phobia.
• Female Only: Females of child bearing potential cannot be pregnant or breastfeeding in order to participate in this study. They must not be planning to become pregnant, and must be willing to use appropriate contraception throughout the study.
• Female Only: To control for hormonal changes related to pregnancy, females will also be excluded if they have previously given birth.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concordia University, Montreal

OTHER

Sponsor Role: lead

Responsible Party

Mark Ellenbogen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Concordia University

Montreal, Quebec, Canada

Countries

Canada

References

Ellenbogen MA, Cardoso C, Serravalle L, Vadaga K, Joober R. The effects of intranasal oxytocin on the efficacy of psychotherapy for major depressive disorder: a pilot randomized controlled trial. Psychol Med. 2024 Jul;54(9):2122-2132. doi: 10.1017/S0033291724000217. Epub 2024 Mar 6.

Reference Type: DERIVED

PMID: 38445382 (View on PubMed)

Other Identifiers

CIHR-12678

Identifier Type: -

Identifier Source: org_study_id