To investigate the association between two polymorphisms of the HTR2C gene (5-HT2c-receptor gene) (3813929 C/T and rs1414334: C>G) and metabolic adverse drug reactions in starters with mirtazapine (5-HT2C-receptor antagonist) versus paroxetine (…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- BMI increase within the study period (0-105 days after start with the
antidepressant)
- Waist circumference increase within the study period (0-105 days after start
with the antidepressant)
Secondary outcome
- Increase of patients with metabolic syndrome at start according to the
criteria of the International Diabetes Federation (IDF) within the study period
(0-105 days after start with the antidepressant)
- SCORE cardiovascular 10-year mortality risk increase within the study period
(0-105 days after start with the antidepressant)
- Increase of fasting glucose level increase within the study period (0-105
days after start with the antidepressant)
- Increase of fasting LDL level increase within the study period (0-105 days
after start with the antidepressant)
- Increase of fasting TC level increase within the study period (0-105 days
after start with the antidepressant)
- Increase of fasting HDL decrease within the study period (0-105 days after
start with the antidepressant)
Background summary
Antidepressants may cause weight gain, lipid abnormalities and hyperglycemia,
which are elements of the metabolic syndrome, leading to more severe
comorbidity, psychosocial consequences, and higher mortality rates. Some
antidepressants have 5-HT2C receptor-blocking properties and antagonism of the
5-HT2C receptor has been hypothesized to represent an important modulator in
feeding behaviour, causing weight gain and insulin resistance. Of the 5-HT2C
receptor, several polymorphisms are known which are associated with obesity and
weight gain in users of antipsychotics. The association between 5-HT2C receptor
polymorphisms and metabolic adverse drug reactions of antidepressants however
has never been studied.
Study objective
To investigate the association between two polymorphisms of the HTR2C gene
(5-HT2c-receptor gene) (3813929 C/T and rs1414334: C>G) and metabolic adverse
drug reactions in starters with mirtazapine (5-HT2C-receptor antagonist) versus
paroxetine (no 5-HT2C-receptor antagonist).
Study design
A prospective controlled follow-up design will be conducted.
Study burden and risks
On inclusion patients will be asked to give consent and fill in a
questionnaire. In addition a health check will be performed which is repeated
with the questionnaire after 105 days. The health check encompasses the
following measurements: blood glucose, LDL, HDL, triglycerides, weight waist
circumference and blood pressure. Finally, a DNA sample from saliva will be
taken. For the glucose, LDL, HDL and triglycerides measurement a blood sample
is needed which will be taken by the finger prick-method. Taking a blood sample
is part of daily medical practice and the risk of the finger prick is
negligible.
Postbus 5500
6130 MB
Nederland
Postbus 5500
6130 MB
Nederland
Listed location countries
Age
Inclusion criteria
- Start of an antidepressant (mirtazapine or paroxetine)
- 18 years or older
- Race: Caucasian (3 of 4 grand parents are Caucasian)
Exclusion criteria
- Abnormal clinical outcomes at the first health check in which a consult with the general practitioner is advised. These outcomes are:
- BMI * 30 kg/m2
- Total cholesterol * 8 mmol/l
- Total cholesterol * 4.5 mmol/l + diabetes
- LDL * 2.5 mmol/l + * 1 risk factor
- Systolic blood pressure * 140 mmHg + * 1 risk factor
- Systolic blood pressure * 160 mmHg
- Glucose > 7.8 mmol/l + BMI * 25 kg/m2
(Risk factors are: smoking, diabetes mellitus, family anamnesis (father, mother, brother or sister) with cardiovascular disease before the age of 60 years.)
- Use of the antidepressant is shorter than 105 days
- Use of other antidepressants during the study period: citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserin, paroxetine, trazodone, venlafaxine, buprorion, amitriptyline, clomipramine, dosulepin, doxepine, imipramine, maprotiline, nortripyline
- Use of atypical antipsychotics during the study period: aripiprazole, clozapine, olanzapine, risperidone, quitiapine, sertindol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19101.096.07 |