Postnatal DepressionNCT04745494
Studies of Mothers With Postnatal Depression
A study testing OT administration in people with Postnatal Depression, run by University College, London at 1 site in United Kingdom.
Trial summary
This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- OT administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2017to 30 Jan 2021
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All mothers will be aged ≥18 years old.
- Mothers in the clinical group will score above the clinical cut-off point on the EPDS.
- Mothers in the control group will score below the clinical cut-off point on the EPDS.
- Mothers must be able to read and write English at a level sufficient to complete study related assessments.
Who cannot join
- If the mother is younger than 18 or post-menopausal
- If the pregnancy was a result of fertility treatment
- If the mother is pregnant
- If the mother has history of psychotic illness
- If the mother is at risk of self-harm
- If the mother is involved in other active drug trials
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).
Read the detailed description
A double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design will be conducted.
Participants will include mothers and their infant in the postnatal period. All participants will be screened for symptoms of low mood on the Edinburgh Postnatal Depression Scale (EPDS) and then assigned into 2 groups comprising probable PND cases and controls.
All participants will take part in 3 conditions at Baseline (before nasal spray administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration), and will complete the same order of tasks.
- Conditions
- Postnatal Depression
- Being tested
- OT administration, Placebo administration
- Keywords
- Oxytocin
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT administrationOther
OT nasal administration
Placebo administrationOther
Placebo nasal administration
| Study group | Role | What they receive |
|---|---|---|
| OT administration | Active comparator | All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray. Receives: Other: OT administration |
| Placebo administration | Placebo comparator | All participants will receive a single dose of a placebo delivered via a nasal spray. Receives: Other: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maternal mood
Change in maternal mood will be assessed using the PANAS questionnaire
Measured: Baseline, 35-45 minutes after intervention administration
Secondary outcomes (5)
Change in maternal mindmindedness
Change in maternal mindmindedness will be assessed using Meins' Mindmindedness Manual
Measured: Baseline, 35-45 minutes after intervention administration
Change in mother-infant interactional style
Change in mother-infant interactional style will be coded using Feldman's Coding Interactive Behaviour Manual
Measured: Baseline, 35-45 minutes after intervention administration
Change in maternal OT
Change in maternal salivary and breast milk OT will be assayed
Measured: Baseline, 35-45 minutes after intervention administration
Change in infant OT
Change in infant salivary OT will be assayed
Measured: Baseline, 35-45 minutes after intervention administration
Maternal gaze during interaction with her infant
Maternal gaze will be assessed using a Tobii X2-30 eye tracker
Measured: 35-45 minutes after intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start12 May 2017
- Primary completion15 Mar 2020
- Study completion30 Jan 2021
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 Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745494
- Sponsor's protocol ID
- 16/0679
- Status last verified
- Feb 2021
- First submitted
- 25 Mar 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lindley Baron-Cohen K, Feldman R, Fearon P, Fonagy P. Intranasal oxytocin administration improves mood in new mothers with moderate low mood but not in mothers with elevated symptoms of postnatal depression: A randomised controlled trial. J Affect Disord. 2022 Mar 1;300:358-365. doi: 10.1016/j.jad.2021.11.062. Epub 2021 Nov 26.
PubMed 34843839
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Mothers With Postnatal Depression
- ClinicalTrials.gov ID
- NCT04745494
- Acronym / sponsor ID
- 16/0679
- Conditions
- Postnatal Depression
- Keywords
- Oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- 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 investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).
Detailed description
A double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design will be conducted.
Participants will include mothers and their infant in the postnatal period. All participants will be screened for symptoms of low mood on the Edinburgh Postnatal Depression Scale (EPDS) and then assigned into 2 groups comprising probable PND cases and controls.
All participants will take part in 3 conditions at Baseline (before nasal spray administration), Condition 1 (after first OT/Placebo administration) and Condition 2 (after second OT/Placebo administration), and will complete the same order of tasks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, case-controlled, randomised controlled-trial, within-subjects, cross-over design.
| Arm | Type | Receives |
|---|---|---|
| OT administration | Active comparator | Other: OT administrationAll participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray. |
| Placebo administration | Placebo comparator | Other: Placebo administrationAll participants will receive a single dose of a placebo delivered via a nasal spray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All mothers will be aged ≥18 years old.
- Mothers in the clinical group will score above the clinical cut-off point on the EPDS.
- Mothers in the control group will score below the clinical cut-off point on the EPDS.
- Mothers must be able to read and write English at a level sufficient to complete study related assessments.
Key exclusion criteria (6 listed)
- If the mother is younger than 18 or post-menopausal
- If the pregnancy was a result of fertility treatment
- If the mother is pregnant
- If the mother has history of psychotic illness
- If the mother is at risk of self-harm
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 |
|---|---|---|
| OT administrationOT nasal administration | Other | OT administration |
| Placebo administrationPlacebo nasal administration | Other | Placebo administration |
Primary outcome
Change in maternal mood
Time frame: Baseline, 35-45 minutes after intervention administration
Change in maternal mood will be assessed using the PANAS questionnaire
5 secondary outcomes
Change in maternal mindmindedness
Time frame: Baseline, 35-45 minutes after intervention administration
Change in mother-infant interactional style
Time frame: Baseline, 35-45 minutes after intervention administration
Change in maternal OT
Time frame: Baseline, 35-45 minutes after intervention administration
Change in infant OT
Time frame: Baseline, 35-45 minutes after intervention administration
Maternal gaze during interaction with her infant
Time frame: 35-45 minutes after intervention administration
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 9 Feb 2021.
- Derived from this study: PubMed 34843839Lindley Baron-Cohen K, Feldman R, Fearon P, Fonagy P. Intranasal oxytocin administration improves mood in new mothers with moderate low mood but not in mothers with elevated symptoms of postnatal depression: A randomised controlled trial. J Affect Disord. 2022 Mar 1;300:358-365. doi: 10.1016/j.jad.2021.11.062. Epub 2021 Nov 26.
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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 study testing OT administration in people with Postnatal Depression, run by University College, London at 1 site in United Kingdom.
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 4 inclusion and 6 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 9 Feb 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 United Kingdom. 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.
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?
Change in maternal mood (time frame: Baseline, 35-45 minutes after intervention administration). 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 NCT04745494, 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 9 Feb 2021.