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Clinical Trials/NCT02774980
NCT02774980
Unknown
Not Applicable

Cognitive Markers of Response to Treatment in Resistant Depression

Centre Hospitalier Universitaire de Nice1 site in 1 country40 target enrollmentJanuary 2015
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
40
Locations
1
Primary Endpoint
Functional assessments : Score Sheehan Disability Scale (SDS)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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