Major Depressive DisorderPhase 2/3TMS/DEPNCT02383693
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
A Phase 2/3 study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
number of center : 1 duration of study : 24 months recruitement time : 23 months Aim :Principal Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients. Secondary Evaluate the impact of rTMS on cognitive functions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Dec 2015
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TRD stage I Thase-Rush
- HDRS + or = 18
- Patients age 18 to 70 years.
- Negative pregnancy test and contraception for women.
- Informed Consent
Who cannot join
- Patient was treated with mood stabilizer in the previous week
- Other disorder on axis I of the DSM IV than depressive disorder.
- Patient with an addiction problem other than tobacco and caféine
- antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
- Previous history of head trauma the previous two years.
- intracranial hypertension.
Show all 9Show fewer
- not affiliated to the social security Patient
- patient under constraint hospitalisation
- Under legal protection measure
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Recherche Clinique
Neuilly-sur-Marne, Île-de-France Region, 93330
Arezki OURRAD, BIOLOGISTE, 0143093232
About this study
number of center : 1
- duration of study : 24 months
- recruitement time : 23 months
- Aim :Principal
Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.
Secondary
Evaluate the impact of rTMS on cognitive functions.
Read the detailed description
The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).
- Conditions
- Major Depressive Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- depression, Repetitive Transcranial Magnetic Stimulation, tolerability, efficiency, TMS, refractory
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called TMS
Repetitive Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| repetitive transcranial magnetic stimulation | Active comparator | Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Sham comparator | Sham comparator | Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
'Hamilton depression rating scale (HDRS)
The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD).
The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.
Measured: one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startJan 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René BENADHIRA, Centre hospitalier de Ville-Evrard, France
- Investigators
- Rene BENADHIRA, MD, Principal investigator, E.P.S ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383693
- Sponsor's protocol ID
- 2007-A00244-49
- Acronym
- TMS/DEP
- Status last verified
- Mar 2015
- First submitted
- 24 Feb 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT02383693
- Acronym / sponsor ID
- TMS/DEP / 2007-A00244-49
- Conditions
- Major Depressive Disorder
- Keywords
- depression, Repetitive Transcranial Magnetic Stimulation, tolerability, efficiency, TMS, refractory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- 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.
number of center : 1
- duration of study : 24 months
- recruitement time : 23 months
- Aim :Principal
Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.
Secondary
Evaluate the impact of rTMS on cognitive functions.
Detailed description
The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation | Active comparator | Device: Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks |
| Sham comparator | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationPlacebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- TRD stage I Thase-Rush
- HDRS + or = 18
- Patients age 18 to 70 years.
- Negative pregnancy test and contraception for women.
- Informed Consent
Key exclusion criteria (9 listed)
- Patient was treated with mood stabilizer in the previous week
- Other disorder on axis I of the DSM IV than depressive disorder.
- Patient with an addiction problem other than tobacco and caféine
- antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
- Previous history of head trauma the previous two years.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: TMSRepetitive Transcranial Magnetic Stimulation | Device | Sham comparator, repetitive transcranial magnetic stimulation |
Primary outcome
'Hamilton depression rating scale (HDRS)
Time frame: one years
The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD). The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
Related trials for Major Depressive Disorder
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
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.
Rene BENADHIRA, MD principal investigator
E.P.S ville Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Centre hospitalier de Ville-Evrard, France 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 9 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 9 Mar 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dominique januel, MD.Phd (0143093232, domjanuel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'Hamilton depression rating scale (HDRS) (time frame: one years). 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 9 Mar 2015.