Condition category
Mental and Behavioural Disorders
Date applied
19/05/2003
Date assigned
19/05/2003
Last edited
04/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony Kendrick

ORCID ID

Contact details

Primary Medical Care Group
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1050
a.r.kendrick@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/70/05

Study information

Scientific title

Acronym

THREAD

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: http://www.hta.ac.uk/1356
Protocol can be found at: http://www.ncchta.org/protocols/200100700005.pdf

Ethics approval

Not provided at time of registration

Study design

Randomised open-label controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

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 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

Drug

Phase

Not Specified

Drug names

Fluoxetine

Primary outcome measures

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

01/09/2003

Overall trial end date

30/01/2008

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

300

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

01/09/2003

Recruitment end date

30/01/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19401066

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