Status:
TERMINATED
Evolution of Dark Ideas When Introducing or Switching an Antidepressant
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Current Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Depression is a frequent disease and a serious public health problem, of which suicide is the most severe complication. Its treatment is based on the introduction of antidepressant which not only prop...
Detailed Description
The study propose to assess, with an ecological momentary assessment method, the evolution of black ideas over 30 days following the introduction or switch of an oral antidepressants. 103 patients wi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of a characterized depressive episode assessed by the clinician
- Depression score : MADRS\> 20
- Introduction or switch of an antidepressant (without combination of molecules)
- Signed informed consent
- Able to understand the nature, purpose and methodology of the study
- French language
- Able to understand and conduct clinical assessments.
- Exclusion criteria:
- The following psychiatric comorbidities: Bipolar disorder, schizophrenia, alcohol dependence and / or any other substance objectivized during the clinical evaluation
- Patient presenting a depressive episode characterized with mixed component, psychotic, melancholic or catatonic characteristics
- Score MADRS greater than or equal to 5 to one of the items
- Subject protected by law (guardianship or curatorship)
- Subject in exclusion period from another protocol
- Subject not affiliated to, or not beneficiary of, a social security scheme
- Pregnant orbreastfeeding patient
Exclusion
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03327974
Start Date
November 24 2017
End Date
April 9 2019
Last Update
September 30 2025
Active Locations (1)
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1
Uhmontpellier
Montpellier, France, 34295