Do Antidepressants Induce Metabolic Syndromes METADAP Study

Major Depressive Disorder Clinical Trial

— METADAP  

Official title:

Do Antidepressants Induce Metabolic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526383
• Other study ID #: P060219
• Status: Completed
• Phase: N/A
• First received: September 5, 2007
• Last updated: April 16, 2014
• Start date: November 2007
• Est. completion date: April 2013

Study information

• Verified date: September 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Metabolic Syndrome X

Intervention

Drug:
• Tricyclic antidepressants
antidepressant version medical dispositive

Locations

Country	Name	City	State
France	Assistance Publique hopital Bicêtre	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia		at Months 0, 1, 3, 6	Yes
Secondary	Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)		at Months 0, 1, 3, 6	No