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 https://doi.org/10.1186/ISRCTN84854789
Secondary identifying numbers HTA 01/70/05
Submission date
19/05/2003
Registration date
19/05/2003
Last edited
04/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anthony Kendrick
Scientific

Primary Medical Care Group
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone +44 (0)23 8024 1050
Email a.r.kendrick@soton.ac.uk

Study information

Study designRandomised open-label controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymTHREAD
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDepression
InterventionPlease 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fluoxetine
Primary outcome measureThe primary outcome measure at 12 and 26 weeks follow-up will be the 17 item Hamilton Depression Rating Scale.
Secondary outcome measuresSecondary 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 study start date01/09/2003
Completion date30/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Key inclusion criteriaPatients 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.
Key exclusion criteriaPatients 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.
Date of first enrolment01/09/2003
Date of final enrolment30/01/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

University Road
Southampton
SO17 1BJ
England
United Kingdom

Website http://www.soton.ac.uk/
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2009 Yes No