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
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
-
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.