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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06110507
Other study ID # 8903
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date March 22, 2024

Study information

Verified date October 2023
Source University Hospital, Strasbourg, France
Contact Jack FOUCHER, MD, PhD
Phone 33 3 88 11 69 21
Email jack.foucher@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A form of depression called 'dopamine-sensitive anergic-anhedonic syndrome is usually resistant to standard therapies (TRAD). On the other hand, they respond to dopaminergic approaches for which recommendations have been developed: DATA ('Dopaminergic Antidepressant Therapy Algorithm'). These are two stages starting with non-selective monoamineoxidase inhibitors (MAOI) or dopamine D2 receptor agonists (D2RAG) in 'monotherapy' (DATA1) and proposing to combine them in the event of a partial response (DATA2). The effectiveness of this approach in the management of TRAD has not yet been evaluated in routine care. The aim of this study is to evaluate the feasibility and effectiveness in routine care of the DATA recommendations in the management of TRAD presenting to a specialized consultation for resistant depression (short and long-term results).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 22, 2024
Est. primary completion date March 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Major patient (=18 years old) - Man or woman - Patient covered for consultation at the Expert Resistant Depression Center of Alsace (CEDRA) (CHU-Strasbourg branch) for TRAD between 01 January 2013 and 31 March 2023 - Patient not opposing to the reuse of their data for the purposes of this research Exclusion Criteria: - Patient having expressed opposition to participating in the study - Patient under judicial protection - Patient under guardianship or curatorship

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients in remission; Remission time; Survival curves for remissions and responses 3 months after the patient was taken care of at the Strasbourg University Hospital
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