TOAD2015: Therapy With an Oxytocin Adjunct for Major Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Drug: Oxytocin nasal spray or placebo
Other Names:
|
| 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. |
Drug: Oxytocin nasal spray or placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score] [Baseline, 4 months later (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)
- Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score] [Baseline, 4 months later (following therapy)]
Inventory for Depressive Symptomology (IDS-C)
- Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score] [Baseline, 4 months later (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)]
- 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] [4 months later (following therapy) and 10 months later (6 months following therapy)]
Hamilton Rating Scale for Depression (HRS-D)
- 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)
- 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)
Secondary Outcome Measures
- Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score] [Baseline, 4 months later (following therapy)]
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
- Biological stress reactivity (Daily Diurnal Cortisol) [Change Score] [Baseline, 4 months later (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)
- 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)
Other Outcome Measures
- Moderation by personality (NEO-PI-R) [Baseline]
NEO-PI-R; Moderation by extraversion
- Mediation by personality (NEO-PI-R) [Change Score] [Baseline up to 10 months later [Slope of Change]]
NEO-PI-R; Mediation by extraversion
- Moderation by attachment (ECR, AAI) [COMPOSITE SCORE] [Baseline]
ECR, AAI: Moderation by attachment style
- Moderation by attachment (ECR, AAI) [COMPOSITE SCORE] [Baseline up to 10 months later [Slope of Change]]
ECR, AAI: Mediation by attachment style
- Adverse Events [Average Score] COMPOSITE [baseline up to 4 months]
In-house measure of adverse events weekly
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Concordia University | Montreal | Quebec | Canada | H4B 1R6 |
Sponsors and Collaborators
- Concordia University, Montreal
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIHR-12678