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

NCT05872555 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 22777

Last updated 2024-03-04

No results posted yet for this study

Summary

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.

Conditions

  • Psychotic Disorders

Interventions

DRUG

Psychiatric Drugs

Receiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer

Sponsors & Collaborators

  • Mark Weiser, MD, Principal Investigator

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-26
Primary Completion
2024-06-01
Completion
2025-01-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872555 on ClinicalTrials.gov