A pilot randomised controlled trial of antidepressant medication switching for treatment-refractory depression in primary care

ISRCTN	ISRCTN39857520
DOI	https://doi.org/10.1186/ISRCTN39857520
Secondary identifying numbers	PALBFWA

Submission date: 15/10/2004
Registration date: 13/01/2005
Last edited: 28/10/2016

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Walters
Scientific

MRC Fellow
Section of Primary Care Mental Health
Institute of Psychiatry
Denmark Hill
London
SE5 8AF
United Kingdom

Email	p.walters@iop.kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A pilot randomised controlled trial of antidepressant medication switching for treatment-refractory depression in primary care
Study acronym	SWITCH
Study objectives	The main hypothesis to be tested is: In depressed primary care patients who have failed to recover after treatment with one antidepressant for at least four weeks and at a standard dose, switching their antidepressant medication to one from a different antidepressant class and continuing it for a further four weeks will be more effective than continuing the initial antidepressant for a further four weeks at the same dose. Secondary hypotheses to be explored are: 1. That there is a positive association between social adversity, the number of life events and the response to antidepressant medications. 2. That non-compliance adversely effects the outcome independently of social adversity and life events 3. That both patient and doctors views of depression and antidepressant medication are associated with response to antidepressant medication
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Depression, Treatment-resistant
Intervention	1. Antidepressant medication switched (intervention): Patients randomised to the intervention arm will have an appointment booked with their GP within 48 hours of the baseline assessment. At this appointment the GP will follow pre-determined guidelines for switching the Selective Serotonin Reuptake Inhibitor (SSRI) to an alternative antidepressant from a different antidepressant class. The Maudsley Prescribing Guidelines (6th Edition) will be used to guide General Practitioners (GPs) switching antidepressants (incorporating the recommended wash-out periods between antidepressant medications). Patients will continue on the second antidepressant for four weeks at a standard dose. For patients unable to tolerate the second antidepressant due to side effects, GPs will follow guidelines to prescribe an alternative antidepressant so that each patient will have a full trial of four weeks on a second antidepressant from a different antidepressant class. The GP will be asked to assess the patient at two and four weeks (following best-practice guidelines) but can see the patient more often as deemed necessary and refer for counselling as necessary. 2. Same antidepressant medication continued (control): Patients randomised to the control arm will have an appointment booked with their GP within 48 hours of the baseline assessment. Patients randomised to the control group will be asked by their GP to continue on the initial SSRI for a further four weeks. The GP will be asked to assess the patient at two and four weeks (following best-practice guidelines) but can see the patient more often as deemed necessary and refer for counselling as necessary.
Intervention type	Other
Primary outcome measure	To determine the feasibility of conducting a larger randomised controlled trial to examine clinical effectiveness of switching an antidepressant medication to another from a different antidepressant class in primary care patients with treatment-refractory depression.
Secondary outcome measures	1. Whether demographic variables, social adversity, life events, physical health and disability, are associated with outcome 2. Whether patient and doctor beliefs about depression and antidepressant medication are associated with outcome
Overall study start date	01/02/2005
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key inclusion criteria	Consenting patients aged 16 years or over with a score of 13 or more on the Hamilton Rating Scale for Depression (HAM-D), 9 or more on the Beck Depression Inventory and who have been compliant with a specific serotonin reuptake inhibitor at a standard dose for at least four weeks (as ascertained by self report questionnaire) will be invited to participate in the study.
Key exclusion criteria	1. Temporary registrations 2. Under 16 years 3. Currently receiving psychological therapies (cognitive behavioural therapy, problem solving therapy, interpersonal therapy) 4. Other psychotropic medications apart from benzodiazepines 5. Case note diagnosis of schizophrenia or bipolar affective disorder 6. Currently being treated for drug or alcohol dependence 7. Suicidal patients 8. Psychotic depression as evidenced by delusions and/or hallucinations 9. Patient treated by secondary psychiatric services 10. Non-English speaking
Date of first enrolment	01/02/2005
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

MRC Fellow

London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Email	G.Dale@iop.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Research council

MRC Clinical research training fellowship

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

28/10/2016: No publications found, verifying study status with principal investigator