PANDA RCT
Research type
Research Study
Full 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
IRAS ID
135094
Contact name
Glyn Lewis
Contact email
Sponsor organisation
University College London
Eudract number
2013-003440-22
ISRCTN Number
ISRCTN84544741
Duration of Study in the UK
2 years, 7 months, 13 days
Research summary
Selective serotonin reuptake inhibitors (SSRIs) are the first line antidepressant recommended by NICE. Many people consult with depressive symptoms and general practitioners (GPs) often feel under pressure to provide some treatment. However, there is still some uncertainty about the severity and duration of depression that are needed for someone to benefit from antidepressants. As a result, GPs often make a difficult decision about whether an individual will benefit from SSRIs.
Most of the previous research trials will have excluded people at lower levels of severity so there might be too little data at the likely thresholds we need to investigate. We therefore propose carrying out a randomised controlled trial comparing sertraline to dummy tablet, placebo, in people with depression. We will include people when the participant and doctor are uncertain about the likely response to antidepressants and are willing to be randomised. We will not specify entry criteria according to severity or duration of symptoms but allow clinical judgement to determine study entry and then investigate our hypotheses concerning severity and duration of symptoms in the analysis of the data.
At baseline, we will use a self-administered computerised questionnaire to asses psychiatric symptoms and also carry out emotional processing tasks that may be a marker of treatment response. We will ask questions about the belief in the efficiency of antidepressants. The 2, 6 and 12 week follow up will also include measures of depressive symptoms, quality of life, adverse effects of antidepressants. Resource use data will be collected from patients and GP records to allow the real costs of treatment to be calculated.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
13/EE/0418
Date of REC Opinion
4 Mar 2014
REC opinion
Further Information Favourable Opinion