Trial record 2 of 518 for:
Open Studies | antidepressants
Do Antidepressants Induce Metabolic Syndromes METADAP Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00526383
First received: September 5, 2007
Last updated: December 12, 2012
Last verified: September 2007
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder |
Drug: Tricyclic antidepressants |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Do Antidepressants Induce Metabolic Syndromes |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI) [ Time Frame: at Months 0, 1, 3, 6 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
antidepressant versus medical dispositive
|
Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Name: antidepressant version medical dispositive
|
| Placebo Comparator: B |
Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Name: antidepressant version medical dispositive
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526383
Contacts
| Contact: Emmanuelle CORRUBLE, MD PhD | +33(0)- 1 45 21 25 24 | emmanuelle.corruble@bct.aphp.fr |
Locations
| France | |
| Assistance Publique hopital Bicêtre | Recruiting |
| Paris, France, 75013 | |
| Contact: Emmanuelle CORRUBLE, MD PhD +33 (0)-1 45 21 25 24 emmanuelle.corruble@bct.aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
| Principal Investigator: | Emmanuelle CORRUBLE, MD PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00526383 History of Changes |
| Other Study ID Numbers: | P060219 |
| Study First Received: | September 5, 2007 |
| Last Updated: | December 12, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Major depressive disorder Antidepressants Weight gain Metabolic syndromes |
Additional relevant MeSH terms:
|
Antidepressive Agents Antidepressive Agents, Tricyclic Depressive Disorder Depression Depressive Disorder, Major Metabolic Syndrome X Mood Disorders Mental Disorders Behavioral Symptoms |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013