Major Depressive DisorderMETADAPNCT00526383
Do Antidepressants Induce Metabolic Syndromes METADAP Study
A study testing Tricyclic antidepressants in people with Major Depressive Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Tricyclic antidepressants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 624 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bipolar disorder (DSM-IV), Psychotic disorder (DSM-IV), Substance abuse or dependence (DSM-IV)
- Normothymic treatment
- Antipsychotic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Antidepressants Induce Metabolic Syndromes
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Tricyclic antidepressants
- Keywords
- Major depressive disorder, Antidepressants, Weight gain, Metabolic syndromes
- Medical subject headings
- Depressive Disorder, Major, Weight Gain, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricyclic antidepressantsDrug
Also called antidepressant version medical dispositive
antidepressant version medical dispositive
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | antidepressant versus medical dispositive Receives: Drug: Tricyclic antidepressants |
| B | Placebo comparator | Not described Receives: Drug: Tricyclic antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia
Measured: at Months 0, 1, 3, 6
Secondary outcomes (1)
Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)
Measured: at Months 0, 1, 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle CORRUBLE, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526383
- Sponsor's protocol ID
- P060219
- Acronym
- METADAP
- Status last verified
- Sep 2007
- First submitted
- 5 Sep 2007
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chappell K, Colle R, El Asmar K, Gressier F, Bouligand J, Trabado S, Feve B, Becquemont L, Corruble E, Verstuyft C. Association of the GRIK4 rs1954787 polymorphism with clinical response in antidepressant-treated depressed patients: results from a prospective cohort and meta-analysis. Mol Psychiatry. 2025 Apr;30(4):1529-1538. doi: 10.1038/s41380-024-02765-5. Epub 2024 Oct 26.
PubMed 39462036Chappell 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.
PubMed 36386175Chappell 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.
PubMed 35878676Loeb 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.
PubMed 33420804Loeb 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.
PubMed 32524920
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Antidepressants Induce Metabolic Syndromes
- ClinicalTrials.gov ID
- NCT00526383
- Acronym / sponsor ID
- METADAP / P060219
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Antidepressants, Weight gain, Metabolic syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tricyclic antidepressantsantidepressant versus medical dispositive |
| B | Placebo comparator | Drug: Tricyclic antidepressants |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Bipolar disorder (DSM-IV), Psychotic disorder (DSM-IV), Substance abuse or dependence (DSM-IV)
- Normothymic treatment
- Antipsychotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricyclic antidepressantsAlso: antidepressant version medical dispositiveantidepressant version medical dispositive | Drug | A, B |
Primary outcome
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
1 secondary outcome
Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI)
Time frame: at Months 0, 1, 3, 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Derived from this study: PubMed 39462036Chappell K, Colle R, El Asmar K, Gressier F, Bouligand J, Trabado S, Feve B, Becquemont L, Corruble E, Verstuyft C. Association of the GRIK4 rs1954787 polymorphism with clinical response in antidepressant-treated depressed patients: results from a prospective cohort and meta-analysis. Mol Psychiatry. 2025 Apr;30(4):1529-1538. doi: 10.1038/s41380-024-02765-5. Epub 2024 Oct 26.
- Derived from this study: PubMed 36386175Chappell 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.
- Derived from this study: PubMed 35878676Chappell 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.
- Derived from this study: PubMed 33420804Loeb 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.
- Derived from this study: PubMed 32524920Loeb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle CORRUBLE, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricyclic antidepressants in people with Major Depressive Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526383, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.