Cognitive Markers of Response to Treatment in Resistant Depression

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Pasteur

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recurrent depression

Behavioral

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: DEP-ICOR

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2020
First posted: May 17, 2016
Registry last updated: Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed