A phase IV, non-­interventional, post-­marketing registry study on the use of Tracydal® (tranylcypromine) for the treatment of treatment-­resistant depression in the Netherlands

Study identification

• EU PAS number:
  EUPAS13809
• Study ID:
  30303
• Official title and acronym:
  A phase IV, non-­interventional, post-­marketing registry study on the use of Tracydal® (tranylcypromine) for the treatment of treatment-­resistant depression in the Netherlands
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  During the registration procedure for Tracydal® market approval, a commitment was made by the applicant to set-up a post-marketing registry study to assess the effectiveness of risk minimisation measures for Tracydal® and to monitor the use of tranylcypromine for the treatment of treatment-resistant depression in the Netherlands.The primary objective is to evaluate if the educational material provided to patients and psychiatrists will be used and appreciated. This will be done by monitoring and evaluating the occurrence of adverse drug events related to hypertensive crisis. The secondary objective is to monitor the overall occurrence of adverse drug events, with the emphasis on: occurrence of convulsion, orthostatic hypotension and serotonin syndrome, exposure during pregnancy, suicidal ideation/behavior and acute toxicity, withdrawal reactions (including delirium) and to assess information related to exposure during human milk, exposure to children and adolescents (<18 years old), renal toxicity. Another secondary objective for the study is to evaluate efficacy based on assessment of depression and social functioning used in standard practice by psychiatrist for diagnosis and efficacy measurements.
• Study status:
  Ongoing

Research institutions and networks

Institutions

DADA Consultancy

Study timelines

Date when funding contract was signed

Planned:02/12/2011

Actual:02/12/2011

Study start date

Planned:17/10/2016

Actual:16/11/2016

Data analysis start date

Planned:15/11/2018

Date of interim report, if expected

Planned:16/02/2018

Actual:14/02/2018

Date of final study report

Planned:16/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Daleco Pharma B.V.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)