Completed

CG25Subgenual Cingulate Stimulation in Resistant Depression

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Behavior

+ Behavioral Symptoms

+ Depression

From 30 to 55 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2007
See protocol details

Summary

Principal SponsorUniversity Hospital, Grenoble
Last updated: October 11, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2007

Actual date on which the first participant was enrolled.

The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25) DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as safety and tolerance by specific psychometric scores. Moreover the protocol aims at highlighting the neurocircuits modulated by CG25 DBS by means of PET (positron emission tomography) imagery

Principal SponsorUniversity Hospital, Grenoble
Last updated: October 11, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsDepression

Criteria

Inclusion criteria: Men and women between 30 and 55 years old Women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion Patient suffering from major unipolar depression refractory to conventional therapies Chronic depression with ongoing depressive episode > 12 months. 4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to ANAES ( Agence Nationale d'Accréditation et d'Evaluation en Santé-the French Health Authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis). Ambulatory or hospital care Able to speak French, understand study procedures and complete questionnaires. Covered by french social health system Living in Rhone-Alpes area without plan to move in the next 2 years Exclusion criteria: History of cerebral surgery Neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (Mattis score < 30) Psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency) Personality disorder of A and B clusters Suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization Severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device. A decrease superior to or equal to 20% in the 17-Hamilton Depression Rating Scale score between inclusion and pre-surgery evaluation Drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine Persons protected by the law.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Neurosurgery department

Grenoble, FranceOpen Neurosurgery department in Google Maps
CompletedOne Study Center