Concordia University
Montreal, Quebec, H4B 1R6, Canada
NCT Number: NCT02405715
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 2
Montreal, Quebec, H4B 1R6, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Syntocinon
Time frame: Baseline, 4 months later (following therapy)
Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
Time frame: Baseline, 4 months later (following therapy)
Hamilton Rating Scale for Depression (HRS-D)
Time frame: Baseline, 4 months later (following therapy)
Inventory for Depressive Symptomology (IDS-C)
Time frame: Baseline, 4 months later (following therapy)
Global Axis of Functioning using the SCID-IV (GAF)
Time frame: includes baseline up to 4 months following baseline assessment (until the end of therapy)
patient dropout rate
Time frame: Baseline up to 10 months later (slope of change over time)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Hamilton Rating Scale for Depression (HRS-D)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Inventory for Depressive Symptomology (IDS-C)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Global Axis of Functioning using the SCID-IV (GAF)
Time frame: Baseline, 4 months later (following therapy)
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Time frame: Baseline, 4 months later (following therapy)
Daily Diurnal Cortisol (2 days)
Time frame: Baseline up to 4 months later (slope of change over time)
Working Alliance Inventory (WAI)
Time frame: Baseline up to 10 months later (slope of change over time)
Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS
Time frame: Baseline up to 10 months later (slope of change over time)
Perceived Stress Scale (PSS)
Time frame: Baseline up to 10 months later (slope of change over time)
Beck Anxiety Inventory (BAI)
Time frame: Baseline up to 4 months later (slope of change over time)
Working Alliance Inventory (WAI)
Time frame: Baseline up to 4 months later (slope of change over time)
Measure by score on Helpful Aspects of Therapy (HAT)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Daily Diurnal Cortisol (2 days)
Time frame: Baseline
NEO-PI-R; Moderation by extraversion
Time frame: Baseline up to 10 months later [Slope of Change]
NEO-PI-R; Mediation by extraversion
Time frame: Baseline
ECR, AAI: Moderation by attachment style
Time frame: Baseline up to 10 months later [Slope of Change]
ECR, AAI: Mediation by attachment style
Time frame: baseline up to 4 months
In-house measure of adverse events weekly
Concordia University, Montreal
Other
Combined Use of Intranasal Oxytocin and Interpersonal Psychotherapy for the Treatment of Major Depressive Disorder (MDD): A Randomized Controlled Trial
Acronym: TOAD2015
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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