Skip to content

Antidepressant drug therapy vs a community-based psychosocial intervention for the treatment of moderate postnatal depression: a pragmatic randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16479417
Enrollment
Unknown
Registered
2003-09-16
Start date
2004-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal depression Mental and Behavioural Disorders Depression

Interventions

A two arm multi-centre pragmatic randomised controlled trial, with randomisation at the level of the individual woman. Women who reach the threshold for inclusion (EPDS>12, CIS-R>11) at 8 weeks will

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with post natal depression up to 3 months post natal

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the EPDS at 4 weeks, 18 weeks and 44 weeks. In addition, the trial will use the SF-36 as a generic measure of functional quality of life, the EQ5D for economic analysis, the MAMA for parenting skills and attitudes towards the baby, the GRIMS for the quality of the marital relationship. The trial will ask partners to complete the GHQ12 the PAPA and the GRIMS. At 12 months we will assess the family milieu using the HOME and the child's development using the Bayley scales.

Secondary

MeasureTime frame
Not provided at time of registration.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026