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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30967

Enrollment

100

Registered

2007-12-04

Start date

2008-04-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity weight gain

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Start of an antidepressant (mirtazapine or paroxetine) - 18 years or older - Race: Caucasian (3 of 4 grand parents are Caucasian)

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

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Countries

Netherlands

Outcome results