Do Antidepressants Induce Metabolic Syndromes METADAP Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Do Antidepressants Induce Metabolic Syndromes

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Tricyclic antidepressants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>antidepressant versus medical dispositive | Drug: Tricyclic antidepressants<br>* antidepressant version medical dispositive<br>* Other names: antidepressant version medical dispositive;|
| Placebo Comparator: B<br> | Drug: Tricyclic antidepressants<br>* antidepressant version medical dispositive<br>* Other names: antidepressant version medical dispositive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia |  | at Months 0, 1, 3, 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI) |  | at Months 0, 1, 3, 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder, Antidepressants, Weight gain, Metabolic syndromes