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Cognitive Markers of Response to Treatment in Resistant Depression

Cognitive Markers of Response to Treatment in Resistant Depression

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02774980
Acronym
DEP-ICOR
Enrollment
30
Registered
2016-05-17
Start date
2015-01-04
Completion date
2020-05-20
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief 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.

Interventions

BEHAVIORALRecurrent depression

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Clinic assessments: Score BDI - IIChange from the baseline score BDI-II at 12 months after introducing the new therapyThe 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)Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapyThe 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)Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapyThe 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNelly Darmon

CHU of Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026