PETRA
Research type
Research Study
Full title
PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA) a double-blind randomised controlled clinical trial to evaluate the addition of pregabalin to primary care patients who have not responded or partially responded to treatment with antidepressants
IRAS ID
1007569
Contact name
Glyn Lewis
Contact email
Sponsor organisation
University College London
Research summary
Generalised anxiety disorder (GAD) is characterised by at least 6 months of symptoms including disproportionate worry, nervousness, poor concentration and sleep disturbance. GAD is a disabling condition that is highly comorbid with depression and other anxiety disorders. The prevalence of GAD is higher than depression in the UK yet is less often recognised in general practice. However, the rate of GAD recorded in primary care has increased dramatically especially in young people. Pregabalin is an effective anti-anxiety drug when used on its own. We want to find out if a combination of an antidepressant and pregabalin is effective for anxiety where the antidepressant alone has not previously been very effective.
AIMS
1) To investigate whether pregabalin, in addition to an antidepressant, is an effective and cost-effective treatment for generalised anxiety disorder (GAD) in people who have not responded to antidepressant treatment
2) To investigate any adverse effects associated with combined treatment of pregabalin and antidepressants
3) To investigate withdrawal symptoms from pregabalin when it is used in combination with antidepressants
4) To investigate the acceptability of prescribing pregabalin in addition to antidepressants for GAD from the perspectives of patients and general practitioners using qualitative methods
Eligible participants will have an ICD11 diagnosis of GAD, be aged 18-74 years, be currently taking an antidepressant and meet a symptom severity criterion. They will not have responded to 2 or more antidepressants.
We will randomise between pregabalin 50-200mg and placebo using a flexible dosing strategy that will mimic usual care and enhance retention. All will receive usual care from their general practitioner who will continue to prescribe their existing antidepressant.
We will follow up the participants for approximately 30 weeks.
for further information please contact cctu.petra@ucl.ac.ukREC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0192
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion