Transcranial Magnetic Stimulation Study of Cortical Excitability as Marker of Antidepressant Response: EXCIPSY Study

NCT ID: NCT03606850

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2020-08-30

Brief Summary

Depression is a common issue but there is no marker of response to an antidepressant treatment.The measurement of variation of the cortical excitability in responders to a selective serotonin reuptake inhibitor (SSRI) (compared to no-responders) had never been done before. In the study of Robol et al. (2004) concerning the acute effects of citalopram on markers of cortical excitability, the authors have pointed out an increase on the cortical silent period (CSP) after administration of citalopram (2.5 hours). The investigators hypothesize that this effect remains later and that the diminution of cortical excitability could be a biomarker of antidepressant response. In this case, they expect that the variation of CSP between day 1 and day 28 is higher in responders to a SSRI (citalopram) compared to non-responders. the investigators lead a pilot, prospective, multicentric study in drug-naive patients to compare the variation of the markers of cortical excitability (the CSP but to the resting motor threshold RMT, the motor evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF) between day 1 and day 28 in responders to citalopram, compared to non-responders.

Conditions

Major Depressive Disorder

Keywords

cortical excitability; marker of response

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment by citalopram

The patients will receive a treatment by citalopram at 20mg/day. If patients respond by at least 20% on the HAMD-21 scale at day 14 : continuation at 20 mg/day. If patients do not respond by at least 20% at day 14 : increase the dose at 40 mg/day. The patients who will not respond by at least 50% on the HAMD-21 scale at day 28 will be excluded of the study and will undergo a new treatment plan. The patients who will respond by at least 50% on HAMD-21 at day 28 will continue citalopram at the same dose and will be reappraised at day 60. The patients will be assessed for the markers of neuroexcitability at day 1, day 3, day 7, day 14, day 28 and day 60.

Group Type: EXPERIMENTAL

Measurements of markers of cortical excitability by TMS

Intervention Type: DEVICE

In the arm experimental "treatment by citalopram", measurements of markers of cortical excitability by Transcranial Magnetic Stimulation will be applied. These measurements were: the cortical silent period CSP, the evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF). Electromagnetic coil is placed upon the vertex, according to the International 10-20 EEG system. Gathering of the peripheral signal by a surface EMG electrode (non invasive device) placed regarding one of the first dorsal interosseous muscle.

Interventions

Measurements of markers of cortical excitability by TMS

In the arm experimental "treatment by citalopram", measurements of markers of cortical excitability by Transcranial Magnetic Stimulation will be applied. These measurements were: the cortical silent period CSP, the evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF). Electromagnetic coil is placed upon the vertex, according to the International 10-20 EEG system. Gathering of the peripheral signal by a surface EMG electrode (non invasive device) placed regarding one of the first dorsal interosseous muscle.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• major depressive episode (according to DSM 5 criteria). Severity of depressive episode assessed by Hamilton Depressive Rating Scale 21 items (HAMD-21) : score > 15 (significant impairment), low suicide risk (score < 2 on suicide item).
• Drug-naive patient (or antidepressant stopped for more than 3 months).
• Patient covered by security social system.
• Patient who is able to read and understand the information paper. Patient who is able to sign the consent.
• For women of childbearing age, effective method of contraception (estrogen-progestin contraceptive or intra-uterine device or tubal ligation) for more than 1 month (negative pregnancy test).

Exclusion Criteria

• Coprescription of psychoactive or neurological drugs known to alter cortical excitability
• Other psychiatric disorders (psychotic disorders, eating disorders).
• Change of antidepressive drug during the study.
• Abuse or addiction at other substances than nicotine or caffeine.
• Unsteady consumption of nicotine or caffeine.
• Dermatologic disease, dementia, medical history of seizure or epilepsy, brain tumor, metallic biomedical implants in brain.
• Ongoing treatment by magnetic or electric stimulation (for example : transcutaneous nerve stimulation or spinal cord stimulation).
• Women of childbearing age without effective contraception, pregnant or breastfeeding.
• Patient who was already included in a clinical trial within 30 days before the inclusion visit.
• Patient deprived of liberty and under guardianship.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role: collaborator

University Hospital Caen, France

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier du Rouvray

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rouvray Hospital

Sotteville-lès-Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maud Rothärmel, MD

Role: CONTACT

Phone: 00 33 2 95 68 25

Email: maud.rotharmel@ch-lerouvray.fr

Aline Augustynen

Role: CONTACT

Phone: 00 33 2 96 68 25

Email: aline.augustynen@ch-lerouvray.fr

Facility Contacts

Maud Rothärmel, MD

Role: primary

Aline Augustynen

Role: backup

Other Identifiers

2018-A00157-48

Identifier Type: -

Identifier Source: org_study_id