Depression and Anxiety Trial, Not Yet Recruiting NCT07188753 Sponsor: Rennes University Hospital Condition: Depression and Anxiety
Back to Depression And Anxiety

Depression and Anxiety Trial, Not Yet Recruiting

NCT07188753
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People aged 65 or older at the time of screening.
  • People who have been diagnosed with Major Depressive Disorder (MDD) and are currently experiencing a major depressive episode, as defined by standard psychiatric guidelines (DSM-5).
  • People whose depression has not responded well enough to antidepressant medications, meaning a switch to a different antidepressant has been considered necessary.
  • People who have never previously received rTMS (repetitive transcranial magnetic stimulation) or iTBS (intermittent theta burst stimulation) treatments.
  • People who have access to ongoing psychiatric care both before and after the study ends.
  • People who will have access to clinical rTMS treatment after the study is completed.
  • People who are in generally good health, based on their medical history, with no serious ongoing medical conditions.
  • People who have read, understood, and signed a consent form agreeing to take part.
  • People who have valid health insurance and are covered by a social security system.
  • People whose depression severity score on a standard rating scale (MADRS) is 20 or higher at screening.
  • People whose score on a standard cognitive screening tool (MoCA) is 26 or below.
  • People who meet all items on the trial's eligibility checklist (confirm with trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have a major cognitive (thinking or memory) disorder, as defined by DSM-5 criteria.
  • People who have a significant primary anxiety disorder, personality disorder, or long-term low-grade depression (dysthymia).
  • People who have been diagnosed with Bipolar Disorder (Type I or II) or a primary psychotic disorder.
  • People who have Autism Spectrum Disorder or an Intellectual Disability.
  • People who have been diagnosed with obsessive-compulsive disorder (OCD).
  • People who currently have a moderate or severe substance use disorder, or who are showing signs of withdrawal from a substance.
  • People who have previously had more than 8 sessions of electroconvulsive therapy (ECT) without it being effective.
  • People who have recently used or are currently using a fast-acting antidepressant such as ketamine, or who have had a course of ECT during their current depressive episode.
  • People with a significant history of neurological disease, including Parkinson's disease, Huntington's disease, brain tumour, seizures or epilepsy, bleeding around the brain (subdural haematoma), multiple sclerosis, or a serious head injury (one that caused a coma, required hospital care, or showed abnormal results on brain imaging).
  • People with a thyroid condition that is untreated or not adequately treated (based on specific hormone levels — confirm with trial site).
  • People who are currently participating in another clinical trial or receiving another experimental treatment.
  • People who have any other condition that the principal investigator (lead doctor) considers could interfere with the study or pose a safety risk.
  • People who have medical reasons that make it unsafe to receive rTMS, such as metal implants in the head, a history of seizures, or a known brain lesion.
  • People who have medical reasons that make it unsafe to have an MRI scan, such as certain metal implants in the body.
  • People taking certain psychiatric or neurological medications that may increase the risk of seizures (such as clozapine) or affect brain activity (such as anti-seizure medications or benzodiazepines) — the lead doctor will assess each case individually; a maximum equivalent dose of 2mg of lorazepam per day may be accepted.
  • Pregnant women, women in labour, and breastfeeding mothers, as well as people who are legally detained or who are under a form of legal guardianship, as outlined in the relevant French Public Health Code articles.
  • People whose score on a standard memory and thinking test (MMSE) is below 21.
  • People who currently have severe insomnia and are unable to sleep at least 5 hours each night before receiving stimulation.
  • People who are currently experiencing mania or psychosis.
  • People who are currently having significant thoughts of suicide, based on a score of 6 or higher on a standard self-report scale (Beck Suicide Scale).
  • People who are currently misusing substances, where the lead doctor considers this a significant safety concern based on clinical assessment or urine/breathalyzer testing.
  • People for whom the calculated treatment dose for the stimulation procedure exceeds 65% of the maximum output of the stimulation device.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: Jean-Marie BATAIL, M.D.,Ph.D., C. H. GUILLAUME REGNIER RENNES

Phone: 0299333937

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Rennes University Hospital
Registry
ClinicalTrials.gov
Start date
15 December 2025
Est. completion
15 June 2031

Primary endpoints

To determine the effect of aiTBS, as compared to sham stimulation, on depressive symptoms at one-month visit (35+/-3 days after the last day of treatment).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov