- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405715
Therapy With an Oxytocin Adjunct for Major Depression (TOAD2015)
Combined Use of Intranasal Oxytocin and Interpersonal Psychotherapy for the Treatment of Major Depressive Disorder (MDD): A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H4B 1R6
- Concordia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 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).
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Other Names:
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Experimental: 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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
Time Frame: Baseline, 4 months later (following therapy)
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Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
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Baseline, 4 months later (following therapy)
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Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D)[Change Score]
Time Frame: Baseline, 4 months later (following therapy)
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Hamilton Rating Scale for Depression (HRS-D)
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Baseline, 4 months later (following therapy)
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Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
Time Frame: Baseline, 4 months later (following therapy)
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Inventory for Depressive Symptomology (IDS-C)
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Baseline, 4 months later (following therapy)
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Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]
Time Frame: Baseline, 4 months later (following therapy)
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Global Axis of Functioning using the SCID-IV (GAF)
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Baseline, 4 months later (following therapy)
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Patient dropout rate [Number of sessions missed]
Time Frame: includes baseline up to 4 months following baseline assessment (until the end of therapy)
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patient dropout rate
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includes baseline up to 4 months following baseline assessment (until the end of therapy)
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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)
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Baseline up to 10 months later (slope of change over time)
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Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
Time Frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
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Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
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4 months later (following therapy) and 10 months later (6 months following therapy)
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Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D) [Change Score]
Time Frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
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Hamilton Rating Scale for Depression (HRS-D)
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4 months later (following therapy) and 10 months later (6 months following therapy)
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Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
Time Frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
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Inventory for Depressive Symptomology (IDS-C)
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4 months later (following therapy) and 10 months later (6 months following therapy)
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Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]
Time Frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
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Global Axis of Functioning using the SCID-IV (GAF)
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4 months later (following therapy) and 10 months later (6 months following therapy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
Time Frame: Baseline, 4 months later (following therapy)
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UCLA Life Stress Interview - Chronic Stress Module (UCLA)
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Baseline, 4 months later (following therapy)
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Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Time Frame: Baseline, 4 months later (following therapy)
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Daily Diurnal Cortisol (2 days)
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Baseline, 4 months later (following therapy)
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Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]
Time Frame: Baseline up to 4 months later (slope of change over time)
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Working Alliance Inventory (WAI)
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Baseline up to 4 months later (slope of change over time)
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Social functioning (patient-rated) (Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS) COMPOSITE SCORE [Change Score]
Time Frame: Baseline up to 10 months later (slope of change over time)
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Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS
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Baseline up to 10 months later (slope of change over time)
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Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]
Time Frame: Baseline up to 10 months later (slope of change over time)
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Perceived Stress Scale (PSS)
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Baseline up to 10 months later (slope of change over time)
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Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score]
Time Frame: Baseline up to 10 months later (slope of change over time)
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Beck Anxiety Inventory (BAI)
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Baseline up to 10 months later (slope of change over time)
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Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI)
Time Frame: Baseline up to 4 months later (slope of change over time)
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Working Alliance Inventory (WAI)
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Baseline up to 4 months later (slope of change over time)
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Usefulness of Therapy (patient-rated); COMPOSITE SCORE
Time Frame: Baseline up to 4 months later (slope of change over time)
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Measure by score on Helpful Aspects of Therapy (HAT)
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Baseline up to 4 months later (slope of change over time)
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Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
Time Frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
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UCLA Life Stress Interview - Chronic Stress Module (UCLA)
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4 months later (following therapy) and 10 months later (6 months following therapy)
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Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Time Frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
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Daily Diurnal Cortisol (2 days)
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4 months later (following therapy) and 10 months later (6 months following therapy)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderation by personality (NEO-PI-R)
Time Frame: Baseline
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NEO-PI-R; Moderation by extraversion
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Baseline
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Mediation by personality (NEO-PI-R) [Change Score]
Time Frame: Baseline up to 10 months later [Slope of Change]
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NEO-PI-R; Mediation by extraversion
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Baseline up to 10 months later [Slope of Change]
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Moderation by attachment (ECR, AAI) [COMPOSITE SCORE]
Time Frame: Baseline
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ECR, AAI: Moderation by attachment style
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Baseline
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Moderation by attachment (ECR, AAI) [COMPOSITE SCORE]
Time Frame: Baseline up to 10 months later [Slope of Change]
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ECR, AAI: Mediation by attachment style
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Baseline up to 10 months later [Slope of Change]
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Adverse Events [Average Score] COMPOSITE
Time Frame: baseline up to 4 months
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In-house measure of adverse events weekly
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baseline up to 4 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR-12678
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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