Studies of Mothers With Postnatal Depression

University College London (UCL)

Status: Completed

Conditions: Postnatal Depression

Treatments: Other: Placebo administration; Other: OT administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04745494

16/0679

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

OT administration

Active Comparator group

Description:

All participants will receive a single dose of 24IU OT (40.32µg, Syntocinon) delivered via a nasal spray.

Treatment:

Other: OT administration

Placebo administration

Placebo Comparator group

Description:

All participants will receive a single dose of a placebo delivered via a nasal spray.

Treatment:

Other: Placebo administration