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

NCT05872555 | Active Not Recruiting

• 1 other identifier: 0277-23-SMC
• Study Type: observational
• Target: 22,777
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Keywords

Antipsychotics; Side effects; Metabolic

Outcome Measures

Primary Outcomes (7)

• Long-term major negative events

  Report 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.

  During follow-up from 2000 to 2021

• Long-term metabolic events

  Diagnosis 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.

  During follow-up from 2000 to 2021

• Long-term metabolic measurements- BMI

  BMI report- using metric units (weight in km/square of height in meters)

  During follow-up from 2000 to 2021

• Long-term metabolic measurements- Cholesterol levels

  Report of cholesterol levels measured in millimoles per liter (mmol/L)

  During follow-up from 2000 to 2021

• Long-term metabolic measurements- Triglycerides levels

  Report of triglyceride levels measured in millimoles per liter (mmol/L)

  During follow-up from 2000 to 2021

• Long-term metabolic measurements- HbA1C levels

  Report of glycated hemoglobin (HbA1C) levels measured in millimoles per moles (mmol/mol)

  During follow-up from 2000 to 2021

• Long-term metabolic measurements- glucose levels

  Report of glucose levels measured in millimoles per liter (mmol/L)

  During follow-up from 2000 to 2021

Study Arms (2)

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

Drug: Psychiatric Drugs

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.

Interventions

Psychiatric Drugs DRUG

Receiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer

Also known as: Antipsychotics, Benzodiazepines, antidepressants, mood stabilizers

Patients with psychiatric diagnosis/prescribed psychiatric medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria for patients include being diagnosed with schizophrenia/schizoaffective disorder/bipolar disorder/depression/other psychiatric diagnoses, and will also include patients receiving these medications who do not have a psychiatric diagnosis. Using psychiatric medications including antipsychotics/antidepressants/mood stabilizers/benzodiazepines as registered in the Clalit database. The study will look at those patients included and will follow them using the CHS database to assess different medical side-effects and the appearance of major negative and major metabolic events, as well as abnormal metabolic measurements. Psychiatric diagnoses by ICD 10 are included if assigned by a psychiatrist or registered following hospital discharge. The validity of these diagnoses has been verified in previous studies (Bieber et al., 2013).

You may qualify if:

• Study Group:
• 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.
• 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.
• Prescription of these psychiatric medications between 2001-2024
• Control Group:
• The control groups will differ according to the analysis performed, and will be clearly described in the publication.
• Depending on the analysis, will not include person prescribed antipsychotics, antidepressants, benzodiazepines, mood stabilizers.
• Matched for age, sex and socio-economic status and other potential confounders, depending on the disease studied.

Sponsors & Collaborators

• Mark Weiser, MD, Principal Investigator: lead

Study Sites (1)

Sheba Medical Center, Psychiatry Department

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Antipsychotic Agents; Benzodiazepines; Antidepressive Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Psychiatry

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 24, 2023
• Study Start: March 26, 2023
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

IL (1)