Major Depressive DisorderEXCIPSYNCT03606850
Transcranial Magnetic Stimulation Study of Cortical Excitability as Marker of Antidepressant Response: EXCIPSY Study
A study testing Measurements of markers of cortical excitability by TMS in people with Major Depressive Disorder, run by Centre Hospitalier du Rouvray at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Measurements of markers of cortical excitability by TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rouvray Hospital
Sotteville-lès-Rouen, 76300
Maud Rothärmel, MD, 00 33 2 95 68 25, maud.rotharmel@ch-lerouvray.fr
Aline Augustynen, 00 33 2 95 68 25, aline.augustynen@ch-lerouvray.fr
About this study
Official title: Pilot Study on the Identification of Cortical Excitability Changes Measured by Transcranial Magnetic Stimulation (TMS) as Markers of Antidepressant Response
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
- Being tested
- Measurements of markers of cortical excitability by TMS
- Keywords
- cortical excitability, marker of response
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Measurements of markers of cortical excitability by TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (8)
Variation of the RMT between day 1 and day 28
The difference in variation of other markers of cortical excitability like resting motor threshold (RMT) between day 1 and day 28 in responders compared to non responders.
Measured: 28 days
Variation of the MEP between day 1 and day 28
The difference in variation of the motor evoked potential (MEP) between day 1 and day 28 in responders compared to non responders.
Measured: 28 days
Variation of the ICI between day 1 and day 28
The difference in variation of the intra-cortical inhibition (ICI) between day 1 and day 28 in responders compared to non responders.
Measured: 28 days
Variation of the ICF between day 1 and day 28
The difference in variation of the intra-cortical facilitation (ICF) between day 1 and day 28 in responders compared to non responders.
Measured: 28 days
Variation of the markers of cortical excitability at other times
Differences in variations of RMT, MEP, ICI and ICF in responders compared to non-responders at other times : between day 1 and day 3, day 1 and day 7 and day 1 and day 14.
Measured: 14 days
Variation in HAMD-21 between day 1 and day 60 for the responders at day 28
The variation in HAMD-21 between day 1 and day 60 for the responders at day 28.
Measured: 60 days
Variations in UKU (Udvalg pour Kliniske Undersøgelser Side Effect Rating Scale) at different times
The variations in UKU scale adapted for antidepressants at day 3, day 7, day 14, day 28 (and day 60 for the responders at day 28). The UKU assesses the side effects of the antidepressants. Its score is between 0 (no side effect) and 120 (the maximum of side effects).
Measured: 60 days
Variations in Morisky compliance scale
The variations in Morisky compliance scale at day 3, day 7, day 14, day 28 (and day 60 for the responders at day 28).The Morisky scale assesses the compliance with antidepressant treatment and its score is between 0 (no compliance) and 8 (good compliance).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start30 Jul 2018 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Rouvray
- Sponsor type
- Other government
- Collaborators
- Centre hospitalier de Ville-Evrard, France, University Hospital Caen, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606850
- Sponsor's protocol ID
- 2018-A00157-48
- Acronym
- EXCIPSY
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Identification of Cortical Excitability Changes Measured by Transcranial Magnetic Stimulation (TMS) as Markers of Antidepressant Response
- ClinicalTrials.gov ID
- NCT03606850
- Acronym / sponsor ID
- EXCIPSY / 2018-A00157-48
- Conditions
- Major Depressive Disorder
- Keywords
- cortical excitability, marker of response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre Hospitalier du RouvrayOther government
- Collaborators
- Centre hospitalier de Ville-Evrard, France, University Hospital Caen, France
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment by citalopram | Experimental | Device: Measurements of markers of cortical excitability by TMSThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of markers of cortical excitability by TMSIn 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. | Device | Treatment by citalopram |
Primary outcome
Variation of the CSP between day 1 and day 28
Time frame: 28 days
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).
8 secondary outcomes
Variation of the RMT between day 1 and day 28
Time frame: 28 days
Variation of the MEP between day 1 and day 28
Time frame: 28 days
Variation of the ICI between day 1 and day 28
Time frame: 28 days
Variation of the ICF between day 1 and day 28
Time frame: 28 days
Variation of the markers of cortical excitability at other times
Time frame: 14 days
Variation in HAMD-21 between day 1 and day 60 for the responders at day 28
Time frame: 60 days
Variations in UKU (Udvalg pour Kliniske Undersøgelser Side Effect Rating Scale) at different times
Time frame: 60 days
Variations in Morisky compliance scale
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements of markers of cortical excitability by TMS in people with Major Depressive Disorder, run by Centre Hospitalier du Rouvray at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Rothärmel, MD (00 33 2 95 68 25, maud.rotharmel@ch-lerouvray.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the CSP between day 1 and day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.