Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Anthony Kendrick


Contact details

Primary Medical Care Group
University of Southampton
Aldermoor Health Centre
Aldermoor Close
SO16 5ST
United Kingdom
+44 (0)23 8024 1050

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 01/70/05

Study information

Scientific title



Study hypothesis

The hypothesis is that fluoxetine treatment will be more effective and cost-effective than supportive care alone among patients scoring 16-19 on the Hamilton Depression Rating Scale (HDRS) but not among those scoring 12-15.

More details can be found at:
Protocol can be found at:

Ethics approval

Not provided at time of registration

Study design

Randomised open-label controlled parallel group trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet




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.

Supportive care from the GP.
Participating GPs will be asked to see patients in both arms for review of symptoms at follow-up appointments two, four, eight, and 12 weeks after randomisation. The GPs will be free to refer patients in both arms for counselling or cognitive-behavioural treatment if this seems appropriate in their judgement. During this 12 week period, the GPs will be asked to refrain from prescribing antidepressants to patients in the control arm, although if patients become worse and in need of antidepressants in the GPs' clinical judgement, patients may be started on drug treatment but will remain in the trial, and be included in the analysis, on an intention to treat basis.
Fluoxetine prescribed by the GP.
GPs will be asked to prescribe fluoxetine for those randomised to the active treatment arm, and will be given instructions on the initial dose (20 mg for patients aged up to 64 and 10 mg for those aged 65 and over) and subsequent titration against response if necessary. At the two week follow-up appointments the GP will determine the patient's response to treatment and address any side effects. If the patient has not responded by the four week follow-up the GP will increase the dose of fluoxetine, assuming there are no side-effects. The GPs will be instructed to change the patient to an alternative drug if they judge that fluoxetine treatment has not been successful by the eight week follow-up. If it does appear successful, the GPs will be advised to continue treatment for four months after recovery.

Intervention type



Not Specified

Drug names


Primary outcome measure

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

Secondary outcome measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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.

Participant type


Age group




Target number of participants


Participant 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.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care Group
SO16 5ST
United Kingdom

Sponsor information


University of Southampton (UK)

Sponsor details

University Road
SO17 1BJ
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2009 results in

Publication citations

  1. Results

    Kendrick T, Chatwin J, Dowrick C, Tylee A, Morriss R, Peveler R, Leese M, McCrone P, Harris T, Moore M, Byng R, Brown G, Barthel S, Mander H, Ring A, Kelly V, Wallace V, Gabbay M, Craig T, Mann A, Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study., Health Technol Assess, 2009, 13, 22, iii-iv, ix-xi, 1-159, doi: 10.3310/hta13220.

Additional files

Editorial Notes