Psychotic DisordersNCT05872555
Side Effects of Psychiatric Medications - a Nested Case Control Cohort Historical Prospective Study
An observational study of Psychotic Disorders, run by Mark Weiser, MD, Principal Investigator at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Psychiatric Drugs
- How many people
- 22,777 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Mar 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Individuals not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Psychiatric Drugs
- Keywords
- Antipsychotics, Side effects, Metabolic
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric DrugsDrug
Also called Antipsychotics, Benzodiazepines, antidepressants, mood stabilizers
Receiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: During follow-up from 2000 to 2021
Long-term metabolic measurements- Cholesterol levels
Report of cholesterol levels measured in millimoles per liter (mmol/L)
Measured: During follow-up from 2000 to 2021
Long-term metabolic measurements- Triglycerides levels
Report of triglyceride levels measured in millimoles per liter (mmol/L)
Measured: 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)
Measured: During follow-up from 2000 to 2021
Long-term metabolic measurements- glucose levels
Report of glucose levels measured in millimoles per liter (mmol/L)
Measured: During follow-up from 2000 to 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start26 Mar 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 22,777 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Weiser, MD, Principal Investigator
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mark Weiser, MD, Principal Investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872555
- Sponsor's protocol ID
- 0277-23-SMC
- Status last verified
- Feb 2024
- First submitted
- 9 May 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effects of Psychiatric Medications - a Nested Case Control Cohort Historical Prospective Study
- ClinicalTrials.gov ID
- NCT05872555
- Acronym / sponsor ID
- 0277-23-SMC
- Conditions
- Psychotic Disorders
- Keywords
- Antipsychotics, Side effects, Metabolic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22,777 participants (estimated)
- Lead sponsor
- Mark Weiser, MD, Principal InvestigatorOther government
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with psychiatric diagnosis/prescribed psychiatric medications | – | Drug: Psychiatric Drugs1. 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (1 listed)
- Individuals not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric DrugsAlso: Antipsychotics, Benzodiazepines, antidepressants, mood stabilizersReceiving any Antipsychotic, Benzodiazepine, antidepressant, mood stabilizer | Drug | Patients with psychiatric diagnosis/prescribed psychiatric medications |
Primary outcome
Long-term major negative events
Time frame: During follow-up from 2000 to 2021
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.
Long-term metabolic events
Time frame: During follow-up from 2000 to 2021
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.
Long-term metabolic measurements- BMI
Time frame: During follow-up from 2000 to 2021
BMI report- using metric units (weight in km/square of height in meters)
Long-term metabolic measurements- Cholesterol levels
Time frame: During follow-up from 2000 to 2021
Report of cholesterol levels measured in millimoles per liter (mmol/L)
Long-term metabolic measurements- Triglycerides levels
Time frame: During follow-up from 2000 to 2021
Report of triglyceride levels measured in millimoles per liter (mmol/L)
Long-term metabolic measurements- HbA1C levels
Time frame: During follow-up from 2000 to 2021
Report of glycated hemoglobin (HbA1C) levels measured in millimoles per moles (mmol/mol)
Long-term metabolic measurements- glucose levels
Time frame: During follow-up from 2000 to 2021
Report of glucose levels measured in millimoles per liter (mmol/L)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders, run by Mark Weiser, MD, Principal Investigator at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term major negative events (time frame: During follow-up from 2000 to 2021). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.