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Completed

NCT Number: NCT00526383

Do Antidepressants Induce Metabolic Syndromes METADAP Study

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.

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Key information

Conditions

Major Depressive Disorder Body Weight Body Weight Changes Depressive Disorder Depressive Disorder, Major Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Mood Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique hopital Bicêtre

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tricyclic antidepressants

Drug

antidepressant version medical dispositive

Other names: antidepressant version medical dispositive

Primary outcomes

  1. 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 outcomes

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

    Time frame: at Months 0, 1, 3, 6

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

Do Antidepressants Induce Metabolic Syndromes

Acronym: METADAP

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2007
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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