Status:
RECRUITING
Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Old Age
Depressive Disorder, Treatment-Resistant
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
To evaluate safety and efficacy of an accelerated deep brain Transcranial Magnetic stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) protocol in an elderly depressed patient pop...
Detailed Description
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increas...
Eligibility Criteria
Inclusion
- • In- and outpatients (age 65 year or older).
- Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for unipolar depression according 17-item Hamilton depression rating scale (HDRS-17) score of 17 or more.
- Failed to respond to at least one adequate course with an antidepressant medication trial, including the current one.
- Intention to continue the current (\>6 weeks) antidepressant treatment at a stable dose dur-ing the stimulation.
- Benzodiazepines are permitted up to a maximum dose of 40 mg diazepam or equivalent. If the dosage has been recently changed, it should be stable for at least 2 weeks.
- Able to read, understand and sign the Informed Consent Form.
Exclusion
- • Psychosis (except depression with psychotic features).
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, substance abuse, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) with the exception of dental fillings. The presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with the following neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with (study related) MRI.
- Patients with cognitive disturbances or dementia (Mini Mental State) \< 24.
- Suicide attempt within 6 months before the start of the study or present high risk of suicide per the investigator's clinical judgment and indicative response\* on the Columbia-Suicide Severity Rating Scale (C-SSRS) and 21-items Beck Scale for Suicide Ideation (BSI). \*'yes' on Item 5 (active suicidal ideation with specific plan and intent).
- Any change in the habitual psychopharmacological agents will be considered as dropout.
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04783103
Start Date
May 7 2021
End Date
July 1 2026
Last Update
November 3 2022
Active Locations (1)
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1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090