Condition category
Mental and Behavioural Disorders
Date applied
15/10/2004
Date assigned
13/01/2005
Last edited
28/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 doctorsÂ’ 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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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