The ANTLER trial is funded by the National Institute of Health Research, and is sponsored by University College London. Professor Glyn Lewis is Chief Investigator.
We would like your practice to identify potential participants via two methods of recruitment, record search with mail out, and during consultation. GP's or other practice staff will not be taking informed consent from participants. Recruitment began in January 2017 and is projected to be open for 2 years.
If a patient meets the study criteria, they will be randomised to either continue with their CURRENT ANTIDEPRESSANT medication (either Citalopram 20mg, Fluoxetine 20mg, Sertraline 100mg or Mirtazapine 30mg) or a matching PLACEBO for 12 months. ANTLER will issue the trial medication bimonthly for 12 months. There will be a 2 month tapering period for those prescribed placebo to reduce withdrawal symptoms. During the trial treatment period, unblinding can happen if there are any concerns regarding a participants' health. The GP will be informed at the end of the treatment period if the participant received the drug or placebo to inform ongoing treatment decisions. The trial medication will be dispensed by University Hospitals Bristol Pharmacy and either posted to your practice or the patient's home address.
Support throughout the trial
Your local ANTLER research team will provide the Practice with advice and support in relation to the trial at all stages and will communicate to you all relevant information regarding your patients.
Financial reimbursement (Service Support Costs)
Reimbursement to the Practice for time spent conducting the Trial will be paid by the local Clinical Research Network (CRN) contingent upon the number of mail-outs, referrals and the number of eligible patients randomised into the study. The ANTLER team will prepare and upload data to facilitate these payments being made.