Side Effects of Psychiatric Medications - a Nested Case Control Cohort Historical Prospective Study

0277-23-SMC

The study is designed to fill in the gaps in current knowledge by providing a more inclusive and comprehensive understanding of the potential associations between different psychiatric medications, including antipsychotics (APs), Antidepressants, Benzodiazepines and mood stabilizers, and negative outcomes, as previous research has often been limited to data from clinical trials. The primary objectives of the study include assessing the association between different psychiatric medications and long-term major negative medical conditions and events. Additionally, the study aims to assess the association between different psychiatric medications and long-term negative metabolic events such as diabetes, obesity, hypertension and hypercholesterolemia. This study aims to investigate the potential long-term negative effects of different psychiatric medications on patients with schizophrenia, schizoaffective disorder, depression, bipolar disorder and dementia, patients with other diagnoses, as well as patients receiving different psychiatric medications who do not have a psychiatric diagnosis. The study will be done using data from the Clalit Health Services (CHS) database, which is the largest provider of health insurance in Israel, serving approximately 55% of the population. This database provides access to all diagnoses and blood tests for the duration of the study, which allows for accurate tracking of patient outcomes over time. Inclusion criteria include being diagnosed with schizophrenia/schizoaffective disorder/bipolar disorder/depression, dementia, other psychiatric diagnoses, and/or patients receiving these medications who do not have a psychiatric diagnosis, and use psychiatric medications, including antipsychotics/antidepressants/mood stabilizers/benzodiazepines as registered in the Clalit database. having first prescription of psychiatric medication between 2001 and 2024. The study will look at those patients included and will follow them using the CHS database to assess these different medical and or metabolic side-effects and the appearance of major negative and major metabolic events, as well as abnormal metabolic measurements.

2023-03-26

2024-06-01

2025-01-01

Active (not recruiting)

22777

Inclusion Criteria: Study Group: 1. Diagnosed with schizophrenia/schizoaffective disorder/bipolar disorder/depression/dementia/diagnosed with other psychiatric disorders, or not diagnoses with any disorder, and registered in the Clalit database. 2. First exposure to antipsychotics/antidepressants/benzodiazepines/mood stabilizers above the age of 16 years, regardless of the presence of having a psychiatric diagnosis. We will include patients treated with these medications also if they do not have a psychiatric diagnosis. 3. Prescription of these psychiatric medications between 2001-2024 Control Group: 1. The control groups will differ according to the analysis performed, and will be clearly described in the publication. 2. Depending on the analysis, will not include person prescribed antipsychotics, antidepressants, benzodiazepines, mood stabilizers. 3. Matched for age, sex and socio-economic status and other potential confounders, depending on the disease studied. Exclusion Criteria: * Individuals not meeting the inclusion criteria.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 22777, 'type': 'ESTIMATED'}}

2024-03-04