Do Antidepressants Induce Metabolic Syndromes METADAP Study - Full Text View

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

MedlinePlus related topics:

Antidepressants Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Official Title:	Do Antidepressants Induce Metabolic Syndromes

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 ]

Estimated Enrollment:	600
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental antidepressant versus medical dispositive	Drug: Tricyclic antidepressants antidepressant version medical dispositive
B: Placebo Comparator	Drug: Tricyclic antidepressants 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

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

Contacts


Contact: Emmanuelle CORRUBLE, MD PhD	+33(0)- 1 45 21 25 24	emmanuelle.corruble@bct.aphp.fr

Locations


France
	Assistance Publique hopital Bicêtre	Recruiting
	PARIS, France, 75013
	Contact: Emmanuelle CORRUBLE, MD PhD +33 (0)-1 45 21 25 24 emmanuelle.corruble@bct.aphp.fr

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

Responsible Party:	Department Clinical Research of Developpement ( Mathieu QUINTIN )
Study ID Numbers:	P060219
First Received:	September 5, 2007
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00526383
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Major depressive disorder

Antidepressants

Weight gain

Metabolic syndromes

Study placed in the following topic categories:

Body Weight

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Weight Gain

Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 16, 2008

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00526383