Do Antidepressants Induce Metabolic Syndromes METADAP Study

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00526383
First received: September 5, 2007
Last updated: April 16, 2014
Last verified: September 2007
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Drug: Tricyclic antidepressants

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Do Antidepressants Induce Metabolic Syndromes

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI) [ Time Frame: at Months 0, 1, 3, 6 ] [ Designated as safety issue: No ]

Enrollment: 624
Study Start Date: November 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
antidepressant versus medical dispositive
Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Name: antidepressant version medical dispositive
Placebo Comparator: B Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Name: antidepressant version medical dispositive

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526383

Locations
France
Assistance Publique hopital Bicêtre
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Emmanuelle CORRUBLE, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00526383     History of Changes
Other Study ID Numbers: P060219
Study First Received: September 5, 2007
Last Updated: April 16, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Major depressive disorder
Antidepressants
Weight gain
Metabolic syndromes

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Metabolic Syndrome X
Mood Disorders
Mental Disorders
Behavioral Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antidepressive Agents
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014