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CADOT: Chronic Anergic-anhedonic Depression Open Trial

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06110507
Collaborator
(none)
60
Enrollment
1
Location
11.7
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Chronic Anergic-anhedonic Depression Open Trial
    Actual Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 22, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06110507
    Other Study ID Numbers:
    • 8903
    First Posted:
    Oct 31, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Depressive Disorder
    Treatment-Resistant
    Anergic-anhednic
    TRD
    TRAD
    MAOI
    dopamine D2 receptor agonists
    D2RAG
    dopamine-sensitive
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Depressive Disorder, Treatment-Resistant

    Study Results

    No Results Posted as of Oct 31, 2023