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Study · Randomized controlled trial · n = 23 · 2024

3 results

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

Ellenbogen MA, Cardoso C, Serravalle L, Vadaga K, Joober R

Psychological medicine6 Mar 2024Cited by 16 (Europe PMC)

PMID38445382 (opens in a new tab)PMCIDPMC11413360 (opens in a new tab)DOI10.1017/s0033291724000217 (opens in a new tab)PepBankPUB-38445382
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Summary

BackgroundAlthough both pharmacotherapy and psychological treatments are considered to be efficacious in the treatment of major depressive disorder (MDD), one third of patients do not respond to treatment and many experience residual symptoms post-treatment. In this double-blind placebo-controlled randomized control trial (RCT), we assessed whether intranasal oxytocin (OT) augments the therapeutic efficacy of psychotherapy for MDD and improves the therapeutic alliance.MethodsTwenty-three volunteers (12 female) with MDD underwent 16 sessions of interpersonal therapy. Prior to each session, volunteers self-administered 24 International Units of intranasal OT (n = 12; Syntocinon) or placebo (n = 11). Depressive symptoms were assessed with the Inventory of Depressive Symptomatology at pre- and post-treatment, and at a six month follow-up.ResultsMultilevel modeling found a significant effect of OT on the negative slope of depressive symptoms over time (p d = 0.75) and follow-up (Cohen's d = 0.82). Drug intervention also predicted the intercept when examining the weekly ratings of the therapeutic alliance (p < 0.05), such that volunteers receiving OT, relative to placebo, reported improved therapeutic alliance at session 1. The agreement of goals between therapists and participants, a facet of the therapeutic alliance, mediated the relationship between drug intervention and clinical outcome.ConclusionIn this pilot study, the administration of intranasal OT, relative to placebo, improved the therapeutic alliance at the beginning of therapy and therapeutic efficacy of psychotherapy in persons with MDD. Future RCTs should attempt to replicate these findings in larger samples with different therapeutic modalities (ClinicalTrials.gov: NCT02405715).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with major depressive disorder in interpersonal therapy, oxytocin steepened the negative slope of depressive symptoms over time compared with placebo, with medium-large effect sizes.

    In plain wordsIn adults with depression receiving talk therapy, oxytocin was linked to a faster fall in depressive symptoms than placebo.

    Peptide
    Oxytocin
    Outcome
    DecreaseDepressive symptoms over time (Inventory of Depressive Symptomatology)
    Study

    n = 23

    Comparator
    Placebo
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    24 International Units · intranasal · 16 sessionsAs given in this study (human).

    Measurements

    Cohen's d
    0.75
    post-treatment
    Cohen's d
    0.82
    six month follow-up

    Source sentences

    Summary
    Multilevel modeling found a significant effect of OT on the negative slope of depressive symptoms over time (p d = 0.75) and follow-up (Cohen's d = 0.82).
    2 context sentences
    Summary · context
    Twenty-three volunteers (12 female) with MDD underwent 16 sessions of interpersonal therapy.
    Summary · context
    Prior to each session, volunteers self-administered 24 International Units of intranasal OT (n = 12; Syntocinon) or placebo (n = 11).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with major depressive disorder in interpersonal therapy, those given oxytocin reported better therapeutic alliance at session 1 than those given placebo.

    In plain wordsIn adults with depression receiving talk therapy, oxytocin was linked to a better therapeutic alliance at the first session than placebo.

    Peptide
    Oxytocin
    Outcome
    IncreaseTherapeutic alliance at session 1
    Study

    n = 23

    Comparator
    Placebo
    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    24 International Units · intranasal · 16 sessionsAs given in this study (human).

    Source sentences

    Summary
    Drug intervention also predicted the intercept when examining the weekly ratings of the therapeutic alliance (p < 0.05), such that volunteers receiving OT, relative to placebo, reported improved therapeutic alliance at session 1.
    2 context sentences
    Summary · context
    Twenty-three volunteers (12 female) with MDD underwent 16 sessions of interpersonal therapy.
    Summary · context
    Prior to each session, volunteers self-administered 24 International Units of intranasal OT (n = 12; Syntocinon) or placebo (n = 11).
  3. 03HumanRandomized controlled trialMechanism

    In adults with major depressive disorder, agreement of goals between therapists and participants mediated the relationship between oxytocin and clinical outcome.

    In plain wordsIn adults with depression, agreement on goals between patient and therapist helped explain how oxytocin related to clinical outcome.

    Peptide
    Oxytocin
    Outcome
    Not applicableMediation by agreement of goals between therapist and participant
    Study

    n = 23

    Outcome group
    Social behavior and cognition · Mental health and mood
    Studied dose
    24 International Units · intranasal · 16 sessionsAs given in this study (human).

    Source sentences

    Summary
    The agreement of goals between therapists and participants, a facet of the therapeutic alliance, mediated the relationship between drug intervention and clinical outcome.
    2 context sentences
    Summary · context
    Twenty-three volunteers (12 female) with MDD underwent 16 sessions of interpersonal therapy.
    Summary · context
    Prior to each session, volunteers self-administered 24 International Units of intranasal OT (n = 12; Syntocinon) or placebo (n = 11).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT02405715

Therapy With an Oxytocin Adjunct for Major Depression

Concordia University, Montrealn = 24Feb 2015 to Aug 2016

Depressive Disorder

Trial pageClinicalTrials.govUpdated 27 Jul 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:47 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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