Freedom of Information request about clinical trials on tricyclic antidepressants submitted to the UK (FOI 21-179)
Published 28 April 2021
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Thank you for your information request, dated 13 February 2021, where you asked for:
“clinical study reports from clinical trials on tricyclic antidepressants submitted to the UK Medicines and Healthcare products Regulatory Agency from the pharmaceutical industry. The trials could be pre-authorization or post-authorization.
We are interested in all randomized controlled clinical trials where any tricyclic antidepressant (amineptine, amitriptyline, amoxapine, butriptyline, clomipramine, desipramine, dibenzepin, dosulepin, doxepin, imipramine, iprindole, lofepramine, maprotiline, nortriptyline, opipramol, protriptyline, tianeptine, and trimipramine) was used for major depressive disorders in adult population and compared to placebo, active placebo or no intervention. This also includes trials where tricyclic antidepressants were used as an active comparator.”
I can confirm that the MHRA does hold some information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further. Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
We advise that you narrow your request by, for example, restrict your FOI request to one specific product licence that you would like the clinical study reports for? Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
The following link of our website page below provides information on Public Assessment Reports (PARs) and this tool can be used to search for PARs for the products you are interested in. https://products.mhra.gov.uk/
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review would be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely
MHRA Customer Service Centre Medicines and Healthcare products Regulatory Agency