In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is an observational, multi-center patient outcome registry to follow the clinical course and outcome
of patients with TRD and who are currently in a major depressive episode (MDE). The study protocol has been amended as follows: Amendment I (P970003/S069) was approved on August 9, 2006. This amendment allows for the recruitment and screening of non-VNS patients at any time during the enrollment period. The TRD registry Amendment II (P970003/S075) was approved on February 12, 2007. This amendment included the addition of the Clinical Global Impression scale (CGI) to the baseline visit and repeat inclusion/exclusion criteria of baseline visit assessments. The TRD registry Amendment III (P970003/S085) was approved on October 23, 2007. This amendment reduces the sample size of non-VNS patients from 1000 to 500 and determines that all the non-VNS patients will be followed up 60 months. The TRD registry Amendment IV (P970003/S091) was approved on December 20, 2007. This amendment reduces the sample size of VNS patients from 1000 to 500 and clarifies that both VNS and non-VNS patients will be followed up 60 months. TRD registry Amendment V requests using the D-21 randomized study patients to augment the VNS group in the TRD registry (currently under FDA review).
Study Population Description
Study population is as per device indication. The device is indicated for the adjunctive long-term
treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Sample Size
500 TRD patients receiving adjunctive VNS Therapy and 500 patients not receiving VNS Therapy. 51
centers initiated, 38 enrolled.
Data Collection
Time until response to treatment is the primary endpoint. Secondary endpoints are time until reponse
and remission, time until recurrence, psychosocial functioning, quality of life, predictors of suicidal attemps and ideation, incremental clinical benefit.
Followup Visits and Length of Followup
All of the patients are planned to be followed for 60 months after enrollment. Visits
include a screening and a baseline visit, and follow up visits at 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after baseline.
