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Trial · Interventional

CompletedPhase 2Registry data

Therapy With an Oxytocin Adjunct for Major Depression

Short name TOAD2015

NCTNCT02405715 (opens ClinicalTrials.gov in a new tab)Other idCIHR-12678
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
24 participants (actual)
Sponsor
Concordia University, Montreal · Other
Design
Randomized · Quadruple masking
Countries
1 country

Canada

Start
Feb 2015
Primary completion
Aug 2016
Completion
Aug 2016
First posted
1 Apr 2015 (estimated)
Last update posted
27 Jul 2021
Conditions
Depressive Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 2

    TOAD2015

    NCT02405715

    Feb 2015 to Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oxytocin nasal spray or placeboDrug

Arms2

  • 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).

  • 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.

Primary outcomes10

Outcomes the sponsor listed as primary.

  1. Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]

    Time frame · Baseline, 4 months later (following therapy)

    Registry description

    Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV

  2. Depressive symptoms (clinician-rated) 9Hamilton Rating Scale for Depression (HRS-D)[Change Score]

    Time frame · Baseline, 4 months later (following therapy)

    Registry description

    Hamilton Rating Scale for Depression (HRS-D)

  3. Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]

    Time frame · Baseline, 4 months later (following therapy)

    Registry description

    Inventory for Depressive Symptomology (IDS-C)

  4. Stress and social functioning (Global Axis of Functioning using the SCID-IV (GAF) [Change Score]

    Time frame · Baseline, 4 months later (following therapy)

    Registry description

    Global Axis of Functioning using the SCID-IV (GAF)

  5. Patient dropout rate [Number of sessions missed]

    Time frame · includes baseline up to 4 months following baseline assessment (until the end of therapy)

    Registry description

    patient dropout rate

  6. 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)

  7. 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)

    Registry description

    Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV

  8. 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)

    Registry description

    Hamilton Rating Scale for Depression (HRS-D)

  9. 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)

    Registry description

    Inventory for Depressive Symptomology (IDS-C)

  10. 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)

    Registry description

    Global Axis of Functioning using the SCID-IV (GAF)

Secondary outcomes(10)

  1. Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]

    Time frame · Baseline, 4 months later (following therapy)

    Registry description

    UCLA Life Stress Interview - Chronic Stress Module (UCLA)

  2. Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]

    Time frame · Baseline, 4 months later (following therapy)

    Registry description

    Daily Diurnal Cortisol (2 days)

  3. Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]

    Time frame · Baseline up to 4 months later (slope of change over time)

    Registry description

    Working Alliance Inventory (WAI)

  4. 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)

    Registry description

    Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS

  5. Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]

    Time frame · Baseline up to 10 months later (slope of change over time)

    Registry description

    Perceived Stress Scale (PSS)

  6. Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score]

    Time frame · Baseline up to 10 months later (slope of change over time)

    Registry description

    Beck Anxiety Inventory (BAI)

  7. Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI)

    Time frame · Baseline up to 4 months later (slope of change over time)

    Registry description

    Working Alliance Inventory (WAI)

  8. Usefulness of Therapy (patient-rated); COMPOSITE SCORE

    Time frame · Baseline up to 4 months later (slope of change over time)

    Registry description

    Measure by score on Helpful Aspects of Therapy (HAT)

  9. 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)

    Registry description

    UCLA Life Stress Interview - Chronic Stress Module (UCLA)

  10. Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]

    Time frame · 4 months later (following therapy) and 10 months later (6 months following therapy)

    Registry description

    Daily Diurnal Cortisol (2 days)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

3 results

The effects of intranasal oxytocin on the efficacy of psychotherapy for major depressive disorder: a pilot randomized controlled trial.

Ellenbogen et al. 2024Psychological medicinecited by 16

PMID 38445382PMC11413360DOI 10.1017/s0033291724000217PUB-38445382

CC BY3 results
Download PDFSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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