Status:
NOT_YET_RECRUITING
Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-burst, Functional Imaging Guided, in the Treatment of Depression in Elderly Subjects With Cognitive Impairment
Lead Sponsor:
Rennes University Hospital
Conditions:
Treatment Resistant Depression
Elderly Depression (≥65y.o.)
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This trial aims at testing a new intensive, personalized functional targeting, transcranial magnetic stimulation technique for elderly patients (aged ≥ 65 years) suffering from a current treatment res...
Detailed Description
Depression in older adults is often associated with cognitive impairment. Executive dysfunction exposes patients to poor response to antidepressants, increased risk of relapse and suicide, and greater...
Eligibility Criteria
Inclusion
- Male or female, of ages ≥ 65 years at the time of screening
- Currently diagnosed with either Major Depressive Disorder (MDD) and meets criteria for a current Major Depressive Episode (MDE) according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- Patients that don't meet the treatment response criteria according to antidepressant treatment history form (ATHF) for whom a switch to another ATD is required.
- rTMS/iTBS naïve.
- Access to ongoing psychiatric care before and after completion of the study.
- Access to clinical rTMS after completion of the study.
- In good general health, as evidenced by medical history (i.e. any ongoing serious and vital medical condition).
- Having signed a free, informed and written consent
- Patients that have a valid health insurance and are affiliated to or beneficiary of a social security system.
- Montgomery and Asberg Depression Rating Scale (MADRS) score of ≥ 20 at screening.
- MoCA total score ≤ 26.
- Comply with eligibility criteria checklist (Appendix 3)
Exclusion
- Major cognitive disorder according to DSM-5 criteria.
- The presence or diagnosis of prominent (primary) anxiety disorder, personality disorder, or dysthymia.
- Bipolar Affective Disorder I \& II and primary psychotic disorders.
- Autism Spectrum disorder or Intellectual Disability.
- A diagnosis of obsessive-compulsive disorder (OCD).
- Current moderate or severe substance use disorder (according to DSM-5 criteria) or demonstrating signs of acute substance withdrawal.
- Any history of ECT (greater than 8 sessions) without meeting response criteria.
- No recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
- History of significant neurologic disease, including Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma (having caused a coma and/or requiring specific hospital care, and/or with abnormal brain imaging).
- Untreated or insufficiently treated dysthyroidism (TSH range 0.4-4mUI/l).
- Treatment with another investigational drug or other intervention within the study period.
- Any other condition deemed by the PI to interfere with the study or increase risk to the participant.
- Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).
- Contraindications to Magnetic Resonance Imaging (MRI) (ferromagnetic metal in their body).
- Participants taking certain psychoactive medications will be assessed for safety by the PI, due to potential for increase of seizure risk (e.g., clozapine) and change in cortical excitability (e.g. anticonvulsant, benzodiazepines). A maximum daily dose of 2mg lorazepam equivalent will be accepted.
- Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code: Pregnant women, women in labour and breastfeeding mothers Person deprived of liberty for judicial or administrative decision, adult person under legal protection (any form of public guardianship).
- Mini Mental Status Examination (MMSE) score \< 21.
- Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation).
- Current mania or psychosis.
- Endorses clinically significant explicit suicidal cognitions (score ≥ 6 on the Beck Suicide Scale \[BSS\] self-report).
- Any current substance abuse that is clinically elicited or based on urine/breathalyzer screening deemed by the PI to be critical from a safety standpoint.
- Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO).
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2031
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT07188753
Start Date
December 15 2025
End Date
December 15 2031
Last Update
September 23 2025
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