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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJuly 27, 2021
July 1, 2021
1.5 years
March 2, 2015
July 21, 2021
Conditions
Outcome Measures
Primary Outcomes (10)
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
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)
Baseline, 4 months later (following therapy)
Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
Inventory for Depressive Symptomology (IDS-C)
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)
Baseline, 4 months later (following therapy)
Patient dropout rate [Number of sessions missed]
patient dropout rate
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]
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
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]
Hamilton Rating Scale for Depression (HRS-D)
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)
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)
4 months later (following therapy) and 10 months later (6 months following therapy)
Secondary Outcomes (10)
Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
Baseline, 4 months later (following therapy)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Baseline, 4 months later (following therapy)
Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]
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]
Baseline up to 10 months later (slope of change over time)
Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]
Baseline up to 10 months later (slope of change over time)
- +5 more secondary outcomes
Other Outcomes (5)
Moderation by personality (NEO-PI-R)
Baseline
Mediation by personality (NEO-PI-R) [Change Score]
Baseline up to 10 months later [Slope of Change]
Moderation by attachment (ECR, AAI) [COMPOSITE SCORE]
Baseline
- +2 more other outcomes
Study Arms (2)
Placebo Spray And Interpersonal Psychotherapy
PLACEBO COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Current Major Depressive Episode
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Concordia University
Montreal, Quebec, H4B 1R6, Canada
Related Publications (1)
Ellenbogen MA, Cardoso C, Serravalle L, Vadaga K, Joober R. The effects of intranasal oxytocin on the efficacy of psychotherapy for major depressive disorder: a pilot randomized controlled trial. Psychol Med. 2024 Jul;54(9):2122-2132. doi: 10.1017/S0033291724000217. Epub 2024 Mar 6.
PMID: 38445382DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 2, 2015
First Posted
April 1, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
July 27, 2021
Record last verified: 2021-07