Do Antidepressants Induce Metabolic Syndromes METADAP Study

NCT ID: NCT00526383

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

antidepressant versus medical dispositive

Group Type EXPERIMENTAL

Tricyclic antidepressants

Intervention Type DRUG

antidepressant version medical dispositive

B

Group Type PLACEBO_COMPARATOR

Tricyclic antidepressants

Intervention Type DRUG

antidepressant version medical dispositive

Interventions

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Tricyclic antidepressants

antidepressant version medical dispositive

Intervention Type DRUG

Other Intervention Names

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antidepressant version medical dispositive

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle CORRUBLE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Assistance Publique hopital Bicêtre

Paris, , France

Site Status

Countries

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France

References

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Chappell K, Ait Tayeb AEK, Colle R, Bouligand J, El-Asmar K, Gressier F, Trabado S, David DJ, Feve B, Becquemont L, Corruble E, Verstuyft C. The association of ARRB1 polymorphisms with response to antidepressant treatment in depressed patients. Front Pharmacol. 2022 Oct 26;13:974570. doi: 10.3389/fphar.2022.974570. eCollection 2022.

Reference Type DERIVED
PMID: 36386175 (View on PubMed)

Chappell K, Colle R, Ait Tayeb AEK, Bouligand J, El-Asmar K, Deflesselle E, Feve B, Becquemont L, Corruble E, Verstuyft C. The ERICH3 rs11580409 polymorphism is associated with 6-month antidepressant response in depressed patients. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Dec 20;119:110608. doi: 10.1016/j.pnpbp.2022.110608. Epub 2022 Jul 22.

Reference Type DERIVED
PMID: 35878676 (View on PubMed)

Loeb E, Becquemont L, Corruble E. Is the decrease in NOx due to a lack of substrate or a NOS inhibition in patients with major depression? : Commentary on Hess et al. 2017. Psychopharmacology (Berl). 2021 Feb;238(2):613-614. doi: 10.1007/s00213-020-05747-x. Epub 2021 Jan 9. No abstract available.

Reference Type DERIVED
PMID: 33420804 (View on PubMed)

Loeb E, El Asmar K, Trabado S, Gressier F, Colle R, Rigal A, Martin S, Verstuyft C, Feve B, Chanson P, Becquemont L, Corruble E. Nitric Oxide Synthase activity in major depressive episodes before and after antidepressant treatment: Results of a large case-control treatment study. Psychol Med. 2022 Jan;52(1):80-89. doi: 10.1017/S0033291720001749. Epub 2020 Jun 11.

Reference Type DERIVED
PMID: 32524920 (View on PubMed)

Other Identifiers

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P060219

Identifier Type: -

Identifier Source: org_study_id

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