PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA)

Phase 4

• Conditions: Generalised Anxiety Disorder (GAD); Mental and Behavioural Disorders

• Registration Number: ISRCTN16993990
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-19
• Last Update Posted: 3 October 2023
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

1. Meeting ICD-11 criteria for generalised anxiety disorder using the revised clinical interview schedule (CIS-R)
2. Scoring =12 on the CIS-R total score
3. Age 18-74 years (upper age limit to ensure the validity of our measures)
4. Currently taking an SSRI, SNRI or mirtazapine in BNF recommended doses for a minimum of 8 weeks prior to randomisation
5. Treatment with at least one other antidepressant before their current antidepressant

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 misuse
4. Current or recent opiate dependence where there is a risk of pregabalin abuse
5. Current use of opiates with a daily dose of >15 morphine milligram equivalents
6. Creatinine clearance <30 ml/min
7. Requirement to use home oxygen machines
8. 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 treatment
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety symptoms measured with GAD7 at 12 weeks as a continuous score