PETRA
Summary
The study aims to compare active pregabalin with an identical placebo as means of investigating the effectiveness and cost-effectiveness of pregabalin. The main objectives are to investigate 1, whether pregabalin, in addition to an antidepressant is an effective treatment for generalised anxiety disorder (GAD) in people who have not responded to antidepressant treatment , 2, whether any adverse effects are associated with combined treatment of pregabalin and antidepressants, 3, if there are any withdrawal symptoms when it is used in combination with antidepressants, and finally 4, to investigate the acceptability of prescribing the two medications together for GAD from the perspectives of patients and GPs using qualitative methods.
Sponsor - University College London
Recruitment End Date - 12/12/2025
Type of Study - Recruiting
RSI Points - 250
Practice Involvement
Practices will act as Research sites with no PI oversight and all activities will take place remotely and will be conducted by the researchers including prescribing.
· Search, brief eligibility check & mailout (via Docmail).
· Data extraction at the end of the study (a search file will be provided for a quick extraction for which CRN support is available).
Eligibility Criteria
Inclusion
Meeting ICD-11 criteria for generalised anxiety disorder.
Scoring ≥12 on the CIS-R total score.
Age 18-74 years.
Currently taking an SSRI, SNRI or mirtazapine in BNF recommended doses for a minimum of 8 weeks prior to randomisation.
Treatment with at least one other antidepressant before their current antidepressant.
Exclusion
Currently taking pregabalin or use within the previous 1 month.
Taking regular antipsychotics.
Have bipolar disorder, psychosis, or alcohol misuse.
Current or recent opiate dependence where there is a risk of pregabalin abuse.
***To express an interest for the PETRA study please use the form provided and a member of the team will be in touch***