Do Antidepressants Induce Metabolic Syndromes METADAP Study

A

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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