Do Antidepressants Induce Metabolic Syndromes METADAP Study

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Tricyclic antidepressants

Study type: Interventional

Funder types: Other

Identifiers

NCT00526383

P060219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 624 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

624 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

antidepressant versus medical dispositive

Treatment:

Drug: Tricyclic antidepressants

B

Placebo Comparator group

Treatment:

Drug: Tricyclic antidepressants