Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05872555
Enrollment
22777
Registered
2023-05-24
Start date
2023-03-26
Completion date
2025-01-01
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders

Keywords

Antipsychotics, Side effects, Metabolic

Brief 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.

Detailed description

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 events such as cancer, osteoporosis, hip fracture, acute myocardial infarction, stroke, tardive dyskinesia, chronic obstructive pulmonary disease, chronic kidney failure and dialysis. 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 The study also aims to assess the association between different psychiatric medications and long-term negative metabolic measurements such as increased body mass index, cholesterol levels, triglyceride levels, Hemoglobin A1C levels and glucose levels, hyperprolactinemia, as well as low eGFR. 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. The preliminary analysis of the study used a sample of 22,777 patients diagnosed with schizophrenia or schizoaffective disorder between the years 2001-2021 in the Clalit dataset. This sample was used to assess whether patients who received at any time clozapine, olanzapine, and quetiapine had a higher risk of major negative and metabolic events. The analysis found that patients who received these medications were at a higher risk of developing metabolic outcomes and most major negative events. Based on these findings, the study aims to have a sample size large enough to detect these associations and allow for meaningful conclusions to be drawn from the data.

Interventions

DRUGPsychiatric Drugs

Receiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer

Sponsors

Mark Weiser, MD, Principal Investigator
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Long-term major negative eventsDuring follow-up from 2000 to 2021Report in national database of cancer, heart disease (heart failure, MI), lung disease (COPD), Tardive dyskinesia, Neurological conditions (CVA, TIA, Epilepsy), , Osteoporosis, hip fracture, chronic kidney disease and dialysis. The database includes a list of reported diseases and major health events, with a score of 0 for no report and a score of 1 for diagnosis of disease.
Long-term metabolic eventsDuring follow-up from 2000 to 2021Diagnosis of Diabetes, Obesity, Hypercholesterolemia, Hypertension. A diagnosis will be considered positive if it appears for at least two years. A composite score will be defined as the appearance of a diagnosis of one or more of the following: diabetes, obesity, hypertension, hypercholesterolemia and hypertriglyceridemia.
Long-term metabolic measurements- BMIDuring follow-up from 2000 to 2021BMI report- using metric units (weight in km/square of height in meters)
Long-term metabolic measurements- Cholesterol levelsDuring follow-up from 2000 to 2021Report of cholesterol levels measured in millimoles per liter (mmol/L)
Long-term metabolic measurements- Triglycerides levelsDuring follow-up from 2000 to 2021Report of triglyceride levels measured in millimoles per liter (mmol/L)
Long-term metabolic measurements- HbA1C levelsDuring follow-up from 2000 to 2021Report of glycated hemoglobin (HbA1C) levels measured in millimoles per moles (mmol/mol)
Long-term metabolic measurements- glucose levelsDuring follow-up from 2000 to 2021Report of glucose levels measured in millimoles per liter (mmol/L)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026