Depressive DisorderPhase 2TOAD2015NCT02405715
Therapy With an Oxytocin Adjunct for Major Depression
A Phase 2 study of Depressive Disorder, run by Concordia University, Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depressive Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current Major Depressive Episode
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Use of Intranasal Oxytocin and Interpersonal Psychotherapy for the Treatment of Major Depressive Disorder (MDD): A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Depressive Disorder
- Being tested
- Oxytocin nasal spray or placebo
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal spray or placeboDrug
Also called Syntocinon
| Study group | Role | What they receive |
|---|---|---|
| Placebo Spray And Interpersonal Psychotherapy | Placebo comparator | Participants will receive 6 sprays of a placebo nasal spray prior to the beginning of each session of interpersonal psychotherapy (16 sessions in total). Receives: Drug: Oxytocin nasal spray or placebo |
| Oxytocin Spray And Interpersonal Psychotherapy | Experimental | 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. Receives: Drug: Oxytocin nasal spray or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
Diagnosis of Major Depressive Episode Will Be Diagnosed Using The SCID-IV
Measured: 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)
Measured: Baseline, 4 months later (following therapy)
Depressive symptoms (clinician-rated) Inventory for Depressive Symptomology (IDS-C) [Change Score]
Inventory for Depressive Symptomology (IDS-C)
Measured: 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)
Measured: Baseline, 4 months later (following therapy)
Patient dropout rate [Number of sessions missed]
patient dropout rate
Measured: 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]
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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]
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Measured: Baseline, 4 months later (following therapy)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Daily Diurnal Cortisol (2 days)
Measured: Baseline, 4 months later (following therapy)
Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]
Working Alliance Inventory (WAI)
Measured: 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]
Social Adjustment Scale- Self-Report (SAS-SR) + MSPSS
Measured: Baseline up to 10 months later (slope of change over time)
Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]
Perceived Stress Scale (PSS)
Measured: Baseline up to 10 months later (slope of change over time)
Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score]
Beck Anxiety Inventory (BAI)
Measured: Baseline up to 10 months later (slope of change over time)
Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI)
Working Alliance Inventory (WAI)
Measured: Baseline up to 4 months later (slope of change over time)
Usefulness of Therapy (patient-rated); COMPOSITE SCORE
Measure by score on Helpful Aspects of Therapy (HAT)
Measured: Baseline up to 4 months later (slope of change over time)
Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
UCLA Life Stress Interview - Chronic Stress Module (UCLA)
Measured: 4 months later (following therapy) and 10 months later (6 months following therapy)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Daily Diurnal Cortisol (2 days)
Measured: 4 months later (following therapy) and 10 months later (6 months following therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ellenbogen, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405715
- Sponsor's protocol ID
- CIHR-12678
- Acronym
- TOAD2015
- Status last verified
- Jul 2021
- First submitted
- 2 Mar 2015
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38445382
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Intranasal Oxytocin and Interpersonal Psychotherapy for the Treatment of Major Depressive Disorder (MDD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02405715
- Acronym / sponsor ID
- TOAD2015 / CIHR-12678
- Conditions
- Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Spray And Interpersonal Psychotherapy | Placebo comparator | Drug: Oxytocin nasal spray or placeboParticipants 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 | Experimental | Drug: Oxytocin nasal spray or placeboParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current Major Depressive Episode
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal spray or placeboAlso: Syntocinon | Drug | Oxytocin Spray And Interpersonal Psychotherapy, Placebo Spray And Interpersonal Psychotherapy |
Primary outcome
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: Baseline, 4 months later (following therapy)
Global Axis of Functioning using the SCID-IV (GAF)
Patient dropout rate [Number of sessions missed]
Time frame: 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]
Time frame: Baseline up to 10 months later (slope of change over time)
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)
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]
Time frame: 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]
Time frame: 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]
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Global Axis of Functioning using the SCID-IV (GAF)
10 secondary outcomes
Stress and social functioning (clinician-rated) (UCLA Life Stress Interview - Chronic Stress Module (UCLA) [Change Score]
Time frame: Baseline, 4 months later (following therapy)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Time frame: Baseline, 4 months later (following therapy)
Working alliance (clinician-rated) (Working Alliance Inventory (WAI) [Change Score]
Time frame: 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]
Time frame: Baseline up to 10 months later (slope of change over time)
Stress (patient-rated) (Perceived Stress Scale (PSS) [Change Score]
Time frame: Baseline up to 10 months later (slope of change over time)
Anxiety (patient-rated) (Beck Anxiety Inventory (BAI) [Change Score]
Time frame: Baseline up to 10 months later (slope of change over time)
Therapeutic Alliance (patient-rated) (Working Alliance Inventory (WAI)
Time frame: Baseline up to 4 months later (slope of change over time)
Usefulness of Therapy (patient-rated); COMPOSITE SCORE
Time frame: Baseline up to 4 months later (slope of change over time)
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)
Biological stress reactivity (Daily Diurnal Cortisol) [Change Score]
Time frame: 4 months later (following therapy) and 10 months later (6 months following therapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 38445382Ellenbogen 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.
Related trials for Depressive Disorder
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Depressive Disorder, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic status: Major Depressive Episode Using The SCID-IV [Change Score] (time frame: Baseline, 4 months later (following therapy)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.