Do Antidepressants Induce Metabolic Syndromes METADAP Study (METADAP)

April 16, 2014 updated by: Assistance Publique - Hôpitaux de Paris

Do Antidepressants Induce Metabolic Syndromes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

624

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Assistance Publique hopital Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Names:
  • antidepressant version medical dispositive
Experimental: A
antidepressant versus medical dispositive
Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Names:
  • antidepressant version medical dispositive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at Months 0, 1, 3, 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Emmanuelle CORRUBLE, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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