NCT03606850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

July 19, 2018

Last Update Submit

July 28, 2018

Conditions

Major Depressive Disorder

Keywords

cortical excitabilitymarker of response

Outcome Measures

Primary Outcomes (1)

  • Variation of the CSP between day 1 and day 28

    The difference in variation of the cortical silent period (CSP) between day 1 and day 28 in responders compared to non-responders. A decrease by at least 50% on Hamilton Depression rating Scale (HAMD-21) define response to citalopram.The HAMD-21 assesses the intensity of the depressive symptoms with 21 items. Its score is between 0 (no depression) and 73 (the maximum of intensity).

    28 days

Secondary Outcomes (8)

  • Variation of the RMT between day 1 and day 28

    28 days

  • Variation of the MEP between day 1 and day 28

    28 days

  • Variation of the ICI between day 1 and day 28

    28 days

  • Variation of the ICF between day 1 and day 28

    28 days

  • Variation of the markers of cortical excitability at other times

    14 days

  • +3 more secondary outcomes

Study Arms (1)

Treatment by citalopram

EXPERIMENTAL

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.

Device: Measurements of markers of cortical excitability by TMS

Interventions

Measurements of markers of cortical excitability by TMSDEVICE

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.

Treatment by citalopram

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 deprived of liberty and under guardianship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouvray Hospital

Sotteville-lès-Rouen, 76300, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Maud Rothärmel, MD

CONTACT

00 33 2 95 68 25maud.rotharmel@ch-lerouvray.fr

Aline Augustynen

CONTACT

00 33 2 96 68 25aline.augustynen@ch-lerouvray.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The patients will assess for markers of cortical excitability (cortical silent period CSP, resting motor threshold RMT, motor evoked potential MEP, intra-cortical inhibition ICI and intra-cortical facilitation ICF) before treatment, at day 3, day 7, day 14, day28 and day 60 with an assessment of depression (HAMD-21).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 31, 2018

Study Start

July 30, 2018

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

FR(1)