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Do Antidepressants Induce Metabolic Syndromes METADAP Study (METADAP)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tricyclic antidepressants
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Antidepressants, Weight gain, Metabolic syndromes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique hopital Bicêtre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

antidepressant versus medical dispositive

Outcomes

Primary Outcome Measures

Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia

Secondary Outcome Measures

Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)

Full Information

First Posted
September 5, 2007
Last Updated
April 16, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT00526383
Brief Title
Do Antidepressants Induce Metabolic Syndromes METADAP Study
Acronym
METADAP
Official Title
Do Antidepressants Induce Metabolic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Antidepressants, Weight gain, Metabolic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
624 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
antidepressant versus medical dispositive
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tricyclic antidepressants
Other Intervention Name(s)
antidepressant version medical dispositive
Intervention Description
antidepressant version medical dispositive
Primary Outcome Measure Information:
Title
Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia
Time Frame
at Months 0, 1, 3, 6
Secondary Outcome Measure Information:
Title
Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)
Time Frame
at Months 0, 1, 3, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle CORRUBLE, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique hopital Bicêtre
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36386175
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.
Results Reference
derived
PubMed Identifier
35878676
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.
Results Reference
derived
PubMed Identifier
33420804
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.
Results Reference
derived

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Do Antidepressants Induce Metabolic Syndromes METADAP Study

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