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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Generalised Anxiety Disorder (GAD)
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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 the 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
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current key exclusion criteria as of 26/11/2025:
1. Currently taking pregabalin or use within the previous 1 month (i.e. wash-out of 1 month required)2. Taking regular antipsychotics 3. Have bipolar disorder, psychosis, or alcohol misuse4. Current or recent opiate dependence where there is a risk of pregabalin abuse5. Current use of opiates with a daily dose of >15 morphine milligram equivalents 6. Creatinine clearance (measured by eGFR is acceptable)7. Requirement to use home oxygen machines daily for respiratory problems8. Experience breathlessness and score ≥3 on the MRC Dyspnoea scale (‘Stops for breath after walking about 100 metres or after a few minutes on the level’ or ‘Too breathless to leave the house or breathless when dressing or undressing’)9. Regular daily use of z drugs >3.75 mg zopiclone or >10mg zolpidem 10. Regular daily use of benzodiazepines or regular night-time use >10mg diazepam or equivalent11. Currently receiving psychotherapy and within 6 months of starting therapy 12. Pregnancy, planned pregnancy and women who are breastfeeding 13. Unable to complete self-administered scales in English (some scales are not validated in other languages) 14. Taking part in another CTIMP
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Previous key exclusion criteria:
1. Currently taking pregabalin or use within the previous 1 month (i.e. wash-out of 1 month required)2. Taking regular antipsychotics 3. Have bipolar disorder, psychosis, or alcohol misuse4. Current or recent opiate dependence where there is a risk of pregabalin abuse5. Current use of opiates with a daily dose of >15 morphine milligram equivalents 6. Creatinine clearance <30 ml/min7. Requirement to use home oxygen machines8. Experience breathlessness and score ≥3 on the MRC Dyspnoea scale (‘Stops for breath after walking about 100 metres or after a few minutes on the level’ or ‘Too breathless to leave the house or breathless when dressing or undressing’)9. Regular daily use of z drugs >3.75 mg zopiclone or >10mg zolpidem 10. Regular daily use of benzodiazepines or regular night-time use >10mg diazepam or equivalent.11. Currently receiving or about to receive psychological treatment12. Pregnancy, planned pregnancy and women who are breastfeeding 13. Unable to complete self-administered scales in English (some scales are not validated in other languages) 14. Taking part in another CTIMP
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University College London and funded by Health Technology Assessment Programme.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.
