Therapy With an Oxytocin Adjunct for Major Depression
- Registration Number
- NCT02405715
- Lead Sponsor
- Concordia University, Montreal
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Spray And Interpersonal Psychotherapy Oxytocin nasal spray or placebo Participants will receive 6 sprays of a placebo nasal spray prior to the beginning of each session of interpersonal psychotherapy (16 sessions in total). Oxytocin Spray And Interpersonal Psychotherapy Oxytocin nasal spray or placebo 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.
- Primary Outcome Measures
Name Time Method Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score] 4 months later (following therapy) and 10 months later (6 months following therapy) Inventory for Depressive Symptomology (IDS-C)
Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D) [Change Score] 4 months later (following therapy) and 10 months later (6 months following therapy) Hamilton Rating Scale for Depression (HRS-D)
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score] 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
Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D)[Change Score] Baseline, 4 months later (following therapy) Hamilton Rating Scale for Depression (HRS-D)
Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score] 4 months later (following therapy) and 10 months later (6 months following therapy) Global Axis of Functioning using the SCID-IV (GAF)
Patient dropout rate [Number of sessions missed] includes baseline up to 4 months following baseline assessment (until the end of therapy) patient dropout rate
Depressive Symptoms (patient-rated) (Beck Depression Inventory-II (BDI-II) [Change Score] Baseline up to 10 months later (slope of change over time)
- Secondary Outcome Measures
Name Time Method Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score] 4 months later (following therapy) and 10 months later (6 months following therapy) UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score] 4 months later (following therapy) and 10 months later (6 months following therapy) Daily Diurnal Cortisol (2 days)
Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score] Baseline up to 4 months later (slope of change over time) Working Alliance Inventory (WAI)
Social functioning (patient-rated) (Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS) COMPOSITE SCORE [Change Score] Baseline up to 10 months later (slope of change over time) Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS
Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score] Baseline up to 10 months later (slope of change over time) Perceived Stress Scale (PSS)
Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score] Baseline up to 10 months later (slope of change over time) Beck Anxiety Inventory (BAI)
Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI) Baseline up to 4 months later (slope of change over time) Working Alliance Inventory (WAI)
Usefulness of Therapy (patient-rated); COMPOSITE SCORE Baseline up to 4 months later (slope of change over time) Measure by score on Helpful Aspects of Therapy (HAT)
Trial Locations
- Locations (1)
Concordia University
🇨🇦Montreal, Quebec, Canada