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CompletedNCT02774980DEP-ICORUpdated Jun 17, 2026

Cognitive Markers of Response to Treatment in Resistant Depression

An observational study in Depression, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
40 Years to 70 Years
Sex
All
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Study summary

Patients with depression are frequently treatment resistant. Clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. Many factors are involved in treatment resistance. As no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment.

The aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and Rush classification).

To explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.

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Conditions studied

  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 30 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a major depressive episode diagnosis

Inclusion criteria

  • Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.

Exclusion criteria

Exclusion Criteria:

  • Patients with major depressive episode during more of 12 months
  • Alzheimer dementia or related disease (CIM 10)
  • Score Hamilton Depression Rating Scale (HDRS) \< 18
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • BehavioralRecurrent depression
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What researchers measure

Primary outcomes

  1. Clinic assessments: Score BDI - II

    The investigators will conduct clinical assessments. A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; 2 weeks after treatment change, patient will be clinically assessed by his psychiatrist. A complete assessment will be done 6 months and 12 months after introducing the new therapy.

    Time frame: Change from the baseline score BDI-II at 12 months after introducing the new therapy

  2. Functional assessments : Score Sheehan Disability Scale (SDS)

    The investigators will conduct functional assessments. A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; 2 weeks after treatment change, patient will be functional assessed by his psychiatrist. A complete assessment will be done 6 months and 12 months after introducing the new therapy.

    Time frame: Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy

  3. Neuropsychologic assessments: M.M.S.E. (Mini Mental Score Evaluation)

    The investigators will conduct neuropsychologic assessments. A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; A complete assessment will be done 6 months and 12 months after introducing the new therapy.

    Time frame: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy

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Study locations

1 site
  • Hopital Pasteur
    Nice, 06000, France
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References and documents

Publications

  • Darmon N, Bulsei J, Gomez S, Bruckert H, Gugenheim L, Riviere K, Dandreis M, Fontas E, Giordana JY, Benoit M. Cognitive impairment and therapeutic response in resistant depression. Encephale. 2025 Apr;51(2):127-132. doi: 10.1016/j.encep.2024.02.002. Epub 2024 May 7. PubMed 38719661 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02774980
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
May 17, 2016
Start date
Jan 4, 2015
Primary completion
May 20, 2019
Completion
May 20, 2020
Last update
Jun 17, 2026

Study contacts

Nelly Darmon
principal investigator · CHU of Nice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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