Condition category
Mental and Behavioural Disorders
Date applied
20/03/2014
Date assigned
20/03/2014
Last edited
09/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Depression is a common condition that affects between 2% and 3% of the population at any one time. Depression is commonly treated with antidepressant medication. In England and Wales there were 47 million prescriptions for antidepressants in 2011. Selective serotonin reuptake inhibitors (SSRIs) are the first-line antidepressant recommended by the NICE guidelines. Some people with depression will recover spontaneously and it is not clear at present which people will benefit from a course of antidepressants. Depression is also difficult to assess accurately during a short primary care consultation. As a result, general practitioners often have to make a difficult decision about whether an individual will benefit from an SSRI. This study is designed to refine the indications for the use of antidepressants in people with depression. Our aim is to investigate the response to sertraline in people with depression by assessing the severity and duration of their depressive symptoms.

Who can participate?
Patients aged 18-74 with depressive symptoms

What does the study involve?
Participants are randomly allocated to take either sertraline or placebo (dummy) capsules for 12 weeks, with assessments at 2, 6 and 12 weeks.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Centre for Mental Health, Addiction and Suicide Research (UK)

When is the study starting and how long is it expected to run for?
May 2014 to May 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Larisa Duffy
L.Duffy@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Larisa Duffy

ORCID ID

Contact details

Centre for Mental Health
Addiction and Suicide Research
Oakfield House
15-23 Oakfield Grove
Bristol
BS8 2BN
United Kingdom
-
L.Duffy@bristol.ac.uk

Additional identifiers

EudraCT number

2013-003440-22

ClinicalTrials.gov number

Protocol/serial number

16264

Study information

Scientific title

A phase IV, double-blind randomised placebo-controlled, parallel group multi-site trial of sertraline compared to placebo in patients presenting with depressive symptoms in primary care where treatment with SSRIs is uncertain. What are the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit? (PANDA RCT)

Acronym

PANDA

Study hypothesis

Depression is a common condition that affects between 2% and 3% of the population at any one time. Depression is commonly treated with antidepressant medication. In England and Wales there were 47m prescriptions for antidepressants in 2011. Selective serotonin reuptake inhibitors (SSRIs) are the first line antidepressant recommended by NICE guidelines. Some people with depression will recover spontaneously and it is not clear at present which people will benefit from a course of antidepressants. Furthermore it is not known whether the current diagnostic criteria for depression as described in ICD10 or DSM5 indicate benefit from antidepressants. Depression is also difficult to assess accurately during a short primary care consultation. As a result, general practitioners often have to make a difficult decision about whether an individual will benefit from an SSRI. This study is designed to refine the indications for the use of antidepressants in people with depression. Our aim is to carry out a randomised controlled trial in order to investigate the severity and duration of depressive symptoms that are associated with a clinically important response to sertraline in people with depression. We plan to assess severity and duration using a standardised assessment that can then be used to guide prescription in primary care. We will include patients presenting in primary care aged 18-74 with depressive symptoms and both the GP and patient are unsure whether there will be significant clinical benefit from taking SSRI antidepressants. Sertraline will be provided in 50mg capsules. The usual dose in primary care is 100mg and we will recommend that all participants take 2 capsules (100mg) unless they cannot tolerate that dose. The participants can increase to 3 capsules if they have not responded and with the agreement of the PI.

Ethics approval

13/EE/0418

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases

Intervention

Sertraline vs. Placebo: The sertraline will be encapsulated and matching placebo capsules produced in order to maintain the blind during the study. Trial treatment will be for 12 weeks with assessments at 2, 6 and 12 weeks. The main treatment response compared to placebo occurs within about 6 weeks. We also want to obtain an early account of adverse events and clinical response at 2 weeks as the first signs of improvement can occur at that point. The 12 week assessment will provide evidence for any sustained benefit.

Follow Up Length: 3 month(s)
Study Entry: Single Randomisation only

Intervention type

Drug

Phase

Phase IV

Drug names

Sertraline

Primary outcome measures

PHQ9 questionnaire that measures depressive symptoms; Timepoint(s): 6 weeks follow up

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/05/2014

Overall trial end date

30/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

We will recruit participants presenting in primary care aged 18-74 with depressive symptoms and both the GP and patient are unsure whether there will be significant clinical benefit from taking SSRI antidepressants and not currently on antidepressants (or in previous 8 weeks). We want to keep the inclusion criteria pragmatic and broad to reflect the current dilemma in clinical practice. We therefore think that the uncertainty of GP and patient about the possible benefits of antidepressants is the key entry criterion for the trial. We have included participants up to 74 years as additional clinical issues concerned with cognitive decline and social care become more common after that age.
There may be situations where people with severe depressions would be included in the study and might receive placebo. The patient will always be free to consult their general practitioner during the study about any of their health concerns. The patient and GP can contact the PI at any time and seek advice about continuing with the study medication to stop the randomised treatment if there was deterioration or any other clinical need to start
antidepressants. We would allow hypnotic medication and other non-pharmacological treatment options including low intensity psychosocial treatments as provided by IAPT or counselling. We will record this information and can
investigate any impact on the findings in secondary analyses (and also use for the economic analysis).
There is marked comorbidity between depression and anxiety disorders. We are relying upon the GP referring subjects into the study to exclude all anxiety disorders that they have identified and wish to treat with SSRIs. We will assess anxiety disorders at baseline and any influence of comorbid anxiety (that we expect will be quite common) on outcome can be examined in exploratory analyses.

Target Gender: Male & Female; Upper Age Limit 74 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 683; UK Sample Size: 683

Participant exclusion criteria

1. Anyone who is incapable of completing the questionnaires or who has other psychiatric disorders including psychosis, bipolar disorder, dementia, eating disorder, substance dependence, schizophrenia, mania, hypomania
2. Known allergies to the IMP, placebo or excipients
3. Poorly controlled epilepsy
4. Hepatic impairment
5. Currently on contraindicated medication: monoamine oxidase Inhibitors within 14 days or pimozide
6. Pregnant women

Recruitment start date

05/05/2014

Recruitment end date

30/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Mental Health, Addiction and Suicide Research
Bristol
BS8 2BN
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK) - Programme Grants for Applied Research; Grant Codes: RP-PG-0610-10048

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

09/06/2016: Plain English summary added.