Skip to content

A randomised controlled trial to determine the cost-effectiveness of fluoxetine for mild to moderate depression with somatic symptoms in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84854789
Enrollment
300
Registered
2003-05-19
Start date
2003-09-01
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

Depression Mental and Behavioural Disorders Depressive episode

Interventions

Please note that, as of 17 January 2008, the anticipated end date of this trial was updated from 30 November 2007 to 31 January 2008. Intervention: Supportive care from the GP. Participating GPs wil

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients attending general practice surgeries who are found by their GPs to be suffering from a new episode of depression and potentially in need of treatment.

Exclusion criteria

Exclusion criteria: Patients are excluded if they fall outside of the HDRS scores mentioned in study summary, if they are already receiving treatment for depression, if they suffer from substance misuse which requires specific treatment, if they have any active suicidal intentions or if they are too physically unwell to participate.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure at 12 and 26 weeks follow-up will be the 17 item Hamilton Depression Rating Scale.

Secondary

MeasureTime frame
Secondary outcome measures will include the Beck Depression Inventory, the Short Form 36 for generic health status, the Client Service Receipt Inventory for service use costs, and a patient satisfaction questionnaire.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026