DepressionDEP-ICORNCT02774980
Cognitive Markers of Response to Treatment in Resistant Depression
An observational study of Depression, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Recurrent depression
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2015to 20 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a major depressive episode diagnosis
Who may be able to join
- Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.
Who cannot join
- Patients with major depressive episode during more of 12 months
- Alzheimer dementia or related disease (CIM 10)
- Score Hamilton Depression Rating Scale (HDRS) < 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression
- Being tested
- Recurrent depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrent depressionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from the baseline score BDI-II at 12 months after introducing the new therapy
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.
Measured: Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy
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.
Measured: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start4 Jan 2015
- Primary completion20 May 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly Darmon, Principal investigator, CHU of Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774980
- Sponsor's protocol ID
- 14-AOI-07
- Acronym
- DEP-ICOR
- Status last verified
- Jun 2026
- First submitted
- 3 May 2016
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Markers of Response to Treatment in Resistant Depression
- ClinicalTrials.gov ID
- NCT02774980
- Acronym / sponsor ID
- DEP-ICOR / 14-AOI-07
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Jan 2015 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a major depressive episode diagnosis
Key inclusion criteria (1 listed)
- Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.
Key exclusion criteria (3 listed)
- Patients with major depressive episode during more of 12 months
- Alzheimer dementia or related disease (CIM 10)
- Score Hamilton Depression Rating Scale (HDRS) < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recurrent depression | Behavioural | – |
Primary outcome
Clinic assessments: Score BDI - II
Time frame: Change from the baseline score BDI-II at 12 months after introducing the new therapy
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.
Functional assessments : Score Sheehan Disability Scale (SDS)
Time frame: Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy
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.
Neuropsychologic assessments: M.M.S.E. (Mini Mental Score Evaluation)
Time frame: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 38719661Darmon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Darmon principal investigator
CHU of Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinic assessments: Score BDI - II (time frame: Change from the baseline score BDI-II at 12 months after introducing the new therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.