Contact information
Type
Scientific
Primary contact
Dr Paul Walters
ORCID ID
Contact details
MRC Fellow
Section of Primary Care Mental Health
Institute of Psychiatry
Denmark Hill
London
SE5 8AF
United Kingdom
-
p.walters@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PALBFWA
Study information
Scientific title
A pilot randomised controlled trial of antidepressant medication switching for treatment-refractory depression in primary care
Acronym
SWITCH
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/02/2005
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/02/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Fellow
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
-
G.Dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
MRC Clinical research training fellowship
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
Basic results (scientific)
Publication list