Clinical trial NCT00526383: Do Antidepressants Induce Metabolic Syndromes METADAP Study
Official title: Do Antidepressants Induce Metabolic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Antidepressants
Weight gain
Metabolic syndromes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2007-09-10
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.

The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.

Detailed description: Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.

The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.

Prospective 6-month naturalistic cohort study, comparing 4 classes of antidepressants (SSRIs, SNRIs, TCAs and others) to a control group (ECT and r-TMS), in 600 patients with a major depressive disorder requiring the beginning of either antidepressant or ECT/r-TMS treatment.

Eligibility criteria: Inclusion Criteria:

* Age : 18-70
* Current major depressive episode (Major depressive disorder) based on the MINI interview
* HAM-D \>18
* Requiring either antidepressant treatment, either ECT or r-TMS (as assessed by the clinician)
* Signed informed consent

Exclusion Criteria:

* Bipolar disorder (DSM-IV), Psychotic disorder (DSM-IV), Substance abuse or dependence (DSM-IV)
* Normothymic treatment
* Antipsychotic treatment

Primary outcomes:
measure: Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia
timeFrame: at Months 0, 1, 3, 6
Secondary outcomes:
measure: Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)
timeFrame: at Months 0, 1, 3, 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique hopital Bicêtre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emmanuelle CORRUBLE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chappell K, Ait Tayeb AEK, Colle R, Bouligand J, El-Asmar K, Gressier F, Trabado S, David DJ, Feve B, Becquemont L, Corruble E, Verstuyft C. The association of ARRB1 polymorphisms with response to antidepressant treatment in depressed patients. Front Pharmacol. 2022 Oct 26;13:974570. doi: 10.3389/fphar.2022.974570. eCollection 2022.
citation: Chappell K, Colle R, Ait Tayeb AEK, Bouligand J, El-Asmar K, Deflesselle E, Feve B, Becquemont L, Corruble E, Verstuyft C. The ERICH3 rs11580409 polymorphism is associated with 6-month antidepressant response in depressed patients. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Dec 20;119:110608. doi: 10.1016/j.pnpbp.2022.110608. Epub 2022 Jul 22.
citation: Loeb E, Becquemont L, Corruble E. Is the decrease in NOx due to a lack of substrate or a NOS inhibition in patients with major depression? : Commentary on Hess et al. 2017. Psychopharmacology (Berl). 2021 Feb;238(2):613-614. doi: 10.1007/s00213-020-05747-x. Epub 2021 Jan 9. No abstract available.