Mortality during US FDA clinical trials in patients with diabetes, hypertension, depression and schizophrenia

Objectives: To evaluate the relationship between the mortality rates associated with psychiatric conditions like depression and schizophrenia compared with chronic medical conditions like hypertension and diabetes. Methods: Examined clinical trial safety data from New Drug Approval programmes review...

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Bibliographic Details
Published in:The world journal of biological psychiatry 2020-01, Vol.21 (1), p.64-71
Main Authors: Khan, Arif, Fahl Mar, Kaysee, Gokul, Sagarika, Brown, Walter A.
Format: Article
Language:English
Subjects:
clinical trials
depression
Mortality
psychopharmacology
schizophrenia
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Summary:Objectives: To evaluate the relationship between the mortality rates associated with psychiatric conditions like depression and schizophrenia compared with chronic medical conditions like hypertension and diabetes. Methods: Examined clinical trial safety data from New Drug Approval programmes reviewed by the US Food and Drug Administration and calculated all-cause and suicide/non-suicide mortality rates per 100,000 patient-exposure-years (PEY) for seven diabetes, 12 hypertension, 11 depression, and nine schizophrenia programmes (126,151 patients, 63,106.3 PEY). Results: Depression (894.8 ± 201.2) and schizophrenia (935.3 ± 214.6) had significantly higher all-cause mortality rates than diabetes (462.8 ± 70.8) and hypertension (448.4 ± 123.1). Psychiatric conditions had 1.9-2.1× the medical conditions' mortality (p 
ISSN:1562-2975
1814-1412
DOI:10.1080/15622975.2018.1514465