Cognitive Markers of Response to Treatment in Resistant Depression

• Conditions: Depression

• Registration Number: NCT02774980
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-13
• Last Update Submitted: 2016-05-13
• Study First Posted: 2016-05-17
• Last Update Posted: 2016-05-17
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional assessments : Score Sheehan Disability Scale (SDS)	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	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)	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.

Trial Locations

Locations (1)

Hopital Pasteur; 🇫🇷 Nice, France