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

NCT ID: NCT05872555

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 22777 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-26
• Study Completion Date: 2025-01-01

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.

Conditions

Psychotic Disorders

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with psychiatric diagnosis/prescribed psychiatric medications

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

Psychiatric Drugs

Intervention Type: DRUG

Receiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer

Control individuals

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.

No interventions assigned to this group

Interventions

Psychiatric Drugs

Receiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer

Intervention Type: DRUG

Other Intervention Names

Antipsychotics, Benzodiazepines, antidepressants, mood stabilizers

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mark Weiser, MD, Principal Investigator

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mark Weiser, MD, Principal Investigator

Head of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sheba Medical Center, Psychiatry Department

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

0277-23-SMC

Identifier Type: -

Identifier Source: org_study_id