Metabolic adverse drug events of antidepressants associated with the serotonin-2C receptor gene: a prospective follow-up study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- BMI increase within the study period (0-105 days after start with the<br /><br>antidepressant)<br /><br>- Waist circumference increase within the study period (0-105 days after start<br /><br>with the antidepressant)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Increase of patients with metabolic syndrome at start according to the<br /><br>criteria of the International Diabetes Federation (IDF) within the study period<br /><br>(0-105 days after start with the antidepressant)<br /><br>- SCORE cardiovascular 10-year mortality risk increase within the study period<br /><br>(0-105 days after start with the antidepressant)<br /><br>- Increase of fasting glucose level increase within the study period (0-105<br /><br>days after start with the antidepressant)<br /><br>- Increase of fasting LDL level increase within the study period (0-105 days<br /><br>after start with the antidepressant)<br /><br>- Increase of fasting TC level increase within the study period (0-105 days<br /><br>after start with the antidepressant)<br /><br>- Increase of fasting HDL decrease within the study period (0-105 days after<br /><br>start with the antidepressant)</p><br>