Clinical trial NCT02405715: Therapy With an Oxytocin Adjunct for Major Depression
Official title: Combined Use of Intranasal Oxytocin and Interpersonal Psychotherapy for the Treatment of Major Depressive Disorder (MDD): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
timeFrame: Baseline, 4 months later (following therapy)
measure: Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D)[Change Score]
timeFrame: Baseline, 4 months later (following therapy)
measure: Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
timeFrame: Baseline, 4 months later (following therapy)
measure: Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]
timeFrame: Baseline, 4 months later (following therapy)
measure: Patient dropout rate [Number of sessions missed]
timeFrame: includes baseline up to 4 months following baseline assessment (until the end of therapy)
measure: Depressive Symptoms (patient-rated) (Beck Depression Inventory-II (BDI-II) [Change Score]
timeFrame: Baseline up to 10 months later (slope of change over time)
measure: Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
timeFrame: 4 months later (following therapy) and 10 months later (6 months following therapy)
measure: Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D) [Change Score]
timeFrame: 4 months later (following therapy) and 10 months later (6 months following therapy)
measure: Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
timeFrame: 4 months later (following therapy) and 10 months later (6 months following therapy)
measure: Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]
timeFrame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Secondary outcomes:
measure: Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
timeFrame: Baseline, 4 months later (following therapy)
measure: Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
timeFrame: Baseline, 4 months later (following therapy)
measure: Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]
timeFrame: Baseline up to 4 months later (slope of change over time)
measure: Social functioning (patient-rated) (Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS) COMPOSITE SCORE [Change Score]
timeFrame: Baseline up to 10 months later (slope of change over time)
measure: Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]
timeFrame: Baseline up to 10 months later (slope of change over time)
measure: Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score]
timeFrame: Baseline up to 10 months later (slope of change over time)
measure: Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI)
timeFrame: Baseline up to 4 months later (slope of change over time)
measure: Usefulness of Therapy (patient-rated); COMPOSITE SCORE
timeFrame: Baseline up to 4 months later (slope of change over time)
measure: Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
timeFrame: 4 months later (following therapy) and 10 months later (6 months following therapy)
measure: Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
timeFrame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Other outcomes:
measure: Moderation by personality (NEO-PI-R)
timeFrame: Baseline
measure: Mediation by personality (NEO-PI-R) [Change Score]
timeFrame: Baseline up to 10 months later [Slope of Change]
measure: Moderation by attachment (ECR, AAI) [COMPOSITE SCORE]
timeFrame: Baseline
measure: Moderation by attachment (ECR, AAI) [COMPOSITE SCORE]
timeFrame: Baseline up to 10 months later [Slope of Change]
measure: Adverse Events [Average Score] COMPOSITE
timeFrame: baseline up to 4 months
Locations:
city: Montreal
country: Canada
facility: Concordia University
state: Quebec
Study officials:
References: