NCT06110507

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

Depressive DisorderTreatment-ResistantAnergic-anhednicTRDTRADMAOIdopamine D2 receptor agonistsD2RAGdopamine-sensitive

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major patient (≥18 years old) 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

You may qualify if:

  • 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

You may not qualify if:

  • Patient having expressed opposition to participating in the study
  • Patient under judicial protection
  • Patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 22, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations