Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05872555 |
| Other study ID # |
0277-23-SMC |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2023 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
