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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Concordia University
Montreal, Quebec, Canada
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
Time frame: Baseline, 4 months later (following therapy)
Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D)[Change Score]
Hamilton Rating Scale for Depression (HRS-D)
Time frame: Baseline, 4 months later (following therapy)
Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
Inventory for Depressive Symptomology (IDS-C)
Time frame: Baseline, 4 months later (following therapy)
Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]
Global Axis of Functioning using the SCID-IV (GAF)
Time frame: Baseline, 4 months later (following therapy)
Patient dropout rate [Number of sessions missed]
patient dropout rate
Time frame: includes baseline up to 4 months following baseline assessment (until the end of therapy)
Depressive Symptoms (patient-rated) (Beck Depression Inventory-II (BDI-II) [Change Score]
Time frame: Baseline up to 10 months later (slope of change over time)
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
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)
Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D) [Change Score]
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Hamilton Rating Scale for Depression (HRS-D)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
Inventory for Depressive Symptomology (IDS-C)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]
Global Axis of Functioning using the SCID-IV (GAF)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Time frame: Baseline, 4 months later (following therapy)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Daily Diurnal Cortisol (2 days)
Time frame: Baseline, 4 months later (following therapy)
Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]
Working Alliance Inventory (WAI)
Time frame: Baseline up to 4 months later (slope of change over time)
Social functioning (patient-rated) (Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS) COMPOSITE SCORE [Change Score]
Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS
Time frame: Baseline up to 10 months later (slope of change over time)
Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]
Perceived Stress Scale (PSS)
Time frame: Baseline up to 10 months later (slope of change over time)
Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score]
Beck Anxiety Inventory (BAI)
Time frame: Baseline up to 10 months later (slope of change over time)
Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI)
Working Alliance Inventory (WAI)
Time frame: Baseline up to 4 months later (slope of change over time)
Usefulness of Therapy (patient-rated); COMPOSITE SCORE
Measure by score on Helpful Aspects of Therapy (HAT)
Time frame: Baseline up to 4 months later (slope of change over time)
Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Daily Diurnal Cortisol (2 days)
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)