Do Antidepressants Induce Metabolic Syndromes METADAP Study

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Tricyclic antidepressants

• Registration Number: NCT00526383
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2007-09
• Study First Submitted: 2007-09-05
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Study Start: 2007-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 624

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tricyclic antidepressants	antidepressant versus medical dispositive
B	Tricyclic antidepressants	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)	at Months 0, 1, 3, 6

Trial Locations

Locations (1)

Assistance Publique hopital Bicêtre; 🇫🇷 Paris, France