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 |
| Protocol serial number | HTA 01/70/05 |
| Sponsor | University of Southampton (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Primary Medical Care Group
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)23 8024 1050 |
|---|---|
| a.r.kendrick@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open-label controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | THREAD |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Fluoxetine |
| Primary outcome measure(s) |
The primary outcome measure at 12 and 26 weeks follow-up will be the 17 item Hamilton Depression Rating Scale. |
| Key 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. |
| Completion date | 30/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 30/01/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
