SchizophreniaNCT02986490
Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs
A study testing Blood sample in people with Schizophrenia and Schizoaffective Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia, dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic could be accompanied by a decrease in the concentration of serum magnesium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Dec 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with severe mental illness (schizophrenia and other disorders chronic psychotic, schizoaffective disorder and bipolar disorder.
- Patient naive to antipsychotic treatment or stopped for more than 3 months (more than 6 months for antipsychotic action extended) and requiring the introduction of antipsychotic therapy
- Patient informed and accepting the proposed follow-up (himself or his/her legal representative)
- Patient available for one year monitoring
- Patient affiliated or beneficiary of a social security insurance
Who cannot join
- patient's opposition
- Pregnant or breastfeeding patient
- Patients on anti-psychotic or treatment stopped for less than 3 months (6 months for antipsychotic prolonged action)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Study site
Montpellier, 34295
Jean-Luc FAILLIE, MD PhD, +33 4 67 33 67 52, jl-faillie@chu-montpellier.fr
About this study
Official title: Influence of Magnesium Variations (Serum and Intra-erythrocyte) on Markers of Cardiometabolic Risk in Long-term Prescription of Antipsychotic Drugs: a Prospective Cohort Study
Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia, dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic could be accompanied by a decrease in the concentration of serum magnesium. Low serum concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock, 2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate metabolism. Most studies on the subject have generally studied plasmatic magnesium.
Objective : Describe the relationship between changes in serum and intra-erythrocyte magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A secondary objective is to specify the frequency, magnitude and time to onset of changes in plasma of magnesium levels under antipsychotic treatment.
Read more
Methods : This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.
Population : patients who are more than 18 years old with schizophrenia schizoaffective disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months and requiring the introduction of antipsychotic drug therapy. Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.
Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the antipsychotic treatment measured by a unique analyzer center. Changes in levels of hypomagnesemia expected during the treatment will determine exposure groups.
Outcome: cardiometabolic risk markers measured at the beginning and during the treatment will be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG (QTc).
Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet, physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and comedications.
Perspectives : to show that decreased in magnesium levels observed among patients starting antipsychotic treatment is associated with deterioration of cardiometabolic risk markers. The demonstration of this association could explain at least part the increased cardiovascular risk observed in this population. In the longer term, the results of this study would argue the implementation of an intervention research project studying magnesium supplementation to minimize the metabolic effects of antipsychotic medications.
Read the detailed description
This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.
Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- Blood sample
- Keywords
- Mental disorders, Antipsychotic agents, Magnesium, Cardiovascular risk factor, Metabolic syndrome
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Mental Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| patient with antipsychotic/neuroleptic | Other | Blood sample performed on patients requiring the establishment of treatment with antipsychotic / neuroleptic Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with changes from baseline cardiometabolic risk
Changes from baseline cardiometabolic risk is defined the following composite outcome : 15% increase in fasting plasma glucose and/or 15% increase in plasma fasting insulin and/or 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5] and/or 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol and/or 2 points increased in BMI and/or increase of 5 cm in waist circumference and/or 10 msec increase in the QTc interval of the ECG.
Measured: At 12 months
Secondary outcomes (11)
Proportion of patients with changes from baseline cardiometabolic risk
Measured: At 3 months
Proportion of patients with changes from baseline cardiometabolic risk
Measured: At 6 months
Proportion of patients with 15% increase in fasting plasma glucose
Measured: From baseline at 12 months
Proportion of patients with 15% increase in plasma fasting insulin
Measured: From baseline at 12 months
Proportion of patients with 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5]
Measured: From baseline at 12 months
Proportion of patients with 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol
Measured: From baseline at 12 months
Proportion of patients with 2 points increased in BMI and/or increase of 5 cm in waist circumference
Measured: From baseline at 12 months
9. Proportion of patients with 10 msec increase in the QTc interval of the ECG
Measured: From baseline at 12 months
Change in zincemia
Measured: From baseline at 12 months
Change in zincemia
Measured: From baseline at 3 months
Change in zincemia
Measured: From baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startSep 2014
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc FAILLIE, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986490
- Sponsor's protocol ID
- UF 9362
- Other IDs
- 2014-A00381-46
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Magnesium Variations (Serum and Intra-erythrocyte) on Markers of Cardiometabolic Risk in Long-term Prescription of Antipsychotic Drugs: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02986490
- Acronym / sponsor ID
- UF 9362
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Keywords
- Mental disorders, Antipsychotic agents, Magnesium, Cardiovascular risk factor, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- 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.
Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia, dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic could be accompanied by a decrease in the concentration of serum magnesium. Low serum concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock, 2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate metabolism. Most studies on the subject have generally studied plasmatic magnesium.
Objective : Describe the relationship between changes in serum and intra-erythrocyte magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A secondary objective is to specify the frequency, magnitude and time to onset of changes in plasma of magnesium levels under antipsychotic treatment.
Methods : This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.
Population : patients who are more than 18 years old with schizophrenia schizoaffective disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months and requiring the introduction of antipsychotic drug therapy. Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.
Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the antipsychotic treatment measured by a unique analyzer center. Changes in levels of hypomagnesemia expected during the treatment will determine exposure groups.
Outcome: cardiometabolic risk markers measured at the beginning and during the treatment will be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG (QTc).
Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet, physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and comedications.
Perspectives : to show that decreased in magnesium levels observed among patients starting antipsychotic treatment is associated with deterioration of cardiometabolic risk markers. The demonstration of this association could explain at least part the increased cardiovascular risk observed in this population. In the longer term, the results of this study would argue the implementation of an intervention research project studying magnesium supplementation to minimize the metabolic effects of antipsychotic medications.
Detailed description
This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.
Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with antipsychotic/neuroleptic | Other | Biological: Blood sampleBlood sample performed on patients requiring the establishment of treatment with antipsychotic / neuroleptic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with severe mental illness (schizophrenia and other disorders chronic psychotic, schizoaffective disorder and bipolar disorder.
- Patient naive to antipsychotic treatment or stopped for more than 3 months (more than 6 months for antipsychotic action extended) and requiring the introduction of antipsychotic therapy
- Patient informed and accepting the proposed follow-up (himself or his/her legal representative)
- Patient available for one year monitoring
- Patient affiliated or beneficiary of a social security insurance
Key exclusion criteria (3 listed)
- patient's opposition
- Pregnant or breastfeeding patient
- Patients on anti-psychotic or treatment stopped for less than 3 months (6 months for antipsychotic prolonged action)
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 |
|---|---|---|
| Blood sampleBlood sample | Biological | patient with antipsychotic/neuroleptic |
Primary outcome
Proportion of patients with changes from baseline cardiometabolic risk
Time frame: At 12 months
Changes from baseline cardiometabolic risk is defined the following composite outcome : 15% increase in fasting plasma glucose and/or 15% increase in plasma fasting insulin and/or 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5] and/or 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol and/or 2 points increased in BMI and/or increase of 5 cm in waist circumference and/or 10 msec increase in the QTc interval of the ECG.
11 secondary outcomes
Proportion of patients with changes from baseline cardiometabolic risk
Time frame: At 3 months
Proportion of patients with changes from baseline cardiometabolic risk
Time frame: At 6 months
Proportion of patients with 15% increase in fasting plasma glucose
Time frame: From baseline at 12 months
Proportion of patients with 15% increase in plasma fasting insulin
Time frame: From baseline at 12 months
Proportion of patients with 15% increase in HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5]
Time frame: From baseline at 12 months
Proportion of patients with 15% increase in total cholesterol levels, or LDL-cholesterol and/or reduction of 15% of HDL-cholesterol
Time frame: From baseline at 12 months
Proportion of patients with 2 points increased in BMI and/or increase of 5 cm in waist circumference
Time frame: From baseline at 12 months
9. Proportion of patients with 10 msec increase in the QTc interval of the ECG
Time frame: From baseline at 12 months
Change in zincemia
Time frame: From baseline at 12 months
Change in zincemia
Time frame: From baseline at 3 months
Change in zincemia
Time frame: From baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Jean-Luc FAILLIE, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Schizophrenia and Schizoaffective Disorder, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 3 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 8 Dec 2016. 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 France. 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?
Contact Jean-Luc FAILLIE, MD PhD (+33 4 67 33 67 52, jl-faillie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with changes from baseline cardiometabolic risk (time frame: At 12 months). 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 8 Dec 2016.