CompletedNot Applicable

Cognitive Markers of Response to Treatment in Resistant Depression

France30 participantsStarted 2015-01-04

Plain-language 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.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinic assessments: Score BDI - II

Timeframe: Change from the baseline score BDI-II at 12 months after introducing the new therapy

Functional assessments : Score Sheehan Disability Scale (SDS)

Timeframe: 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)

Timeframe: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy

Trial details

NCT IDNCT02774980

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-05-20

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