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A randomised controlled trial to determine the cost-effectiveness of fluoxetine for mild to moderate depression with somatic symptoms in primary care
ISRCTN ISRCTN84854789
DOI 10.1186/ISRCTN84854789
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial to determine the cost-effectiveness of fluoxetine for mild to moderate depression with somatic symptoms in primary care
Scientific title
Acronym THREAD
Serial number at source HTA 01/70/05
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
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised open-label controlled parallel group trial
Countries of recruitment United Kingdom
Disease/condition/study domain Depression
Participants - 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.
Participants - 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.
Anticipated start date 01/09/2003
Anticipated end date 30/01/2008
Status of trial Completed
Patient information material
Target number of participants 300
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 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.
Primary outcome measure(s) The primary outcome measure at 12 and 26 weeks follow-up will be the 17 item Hamilton Depression Rating Scale.
Secondary outcome measure(s) 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.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19401066
Contact name Prof  Anthony  Kendrick
  Address Primary Medical Care Group
University of Southampton
Aldermoor Health Centre
Aldermoor Close
  City/town Southampton
  Zip/Postcode SO16 5ST
  Country United Kingdom
  Tel +44 (0)23 8024 1050
  Fax +44 (0)23 8070 1125
  Email a.r.kendrick@soton.ac.uk
Sponsor University of Southampton (UK)
  Address University Road
  City/town Southampton
  Zip/Postcode SO17 1BJ
  Country United Kingdom
  Sponsor website: http://www.soton.ac.uk/
Date applied 19/05/2003
Last edited 04/08/2009
Date ISRCTN assigned 19/05/2003
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