NCT05855850Completed
Deep rTMS for Depression in Older Adults
DIfferential Feasibility and Tolerability of Deep repetitiVe transcranIal MagNEtic Stimulation for Depression in Older Adults (DIVINE Trial): A Pilot Study
Source: ClinicalTrials.gov · Last updated 17 Jun 2024
Brief summary (registry, in English)
This study aims to: (1) assess the feasibility and tolerability of two active dTMS coils - H4 and H7 - in older adults with depression; and (2) clinical response measured by change from baseline on the Hamilton Depression Rating Scale- 24 item; changes in cognitive function through neuropsychological assessment; and changes in regional electrophysiological activity and functional connectivity indexed by EEG. Through a parallel design, participants will complete a four-week course of five dTMS sessions per week, for a total of 20 stimulation sessions. Participants will be randomly assigned to either coil (H4 or H7) and will complete questionnaires examining side effects, mental health symptoms, and cognition. Participant EEG data will be measured and collected at baseline and at the end of each week. Collectively, the study will address the absolute and differential feasibility and tolerability of the two active coils to provide preliminary data for a future randomized controlled trial comparing one or both of these novel interventions to the established H1-coil and a sham stimulation (placebo) control.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 6 Feb 2023
- Start date
- 18 Apr 2023
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Diseases
- Depression
- NCT number
- NCT05855850
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 18 Apr 2023 to the primary completion date, 3 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Substance dependence/abuse in the past 3 months before entering the study (this will be screened via self-report and verified by urine screening test)
Other illness
- Primary diagnosis of bipolar I or II disorder; psychotic disorder; obsessive-compulsive, post-traumatic stress, anxiety, or personality disorder; participants with anxiety or personality disorders will be eligible if is not their primary diagnosis
- Possible dementia diagnosis based on a Mini Mental Status Exam (MMSE) score of \<24 and clinical presentation of dementia
Lab values
- Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion \>300 mg/day as it is associated with risk of seizures, treatment with equivalent benzodiazepine dose to lorazepam \>2 mg/day
Other
- Active suicidal behavior
- Unsuccessful ECT treatment on the current episode
- People with severe literacy, visual, or hearing issues that affect their ability to engage in the interviews
- People with recurring migraines or headaches (weekly or more).
- Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities.
Who the study is looking for
- 60 - 85 years old
- Able to provide informed consent to participate in the study
- MDD diagnosis, single or recurrent episode, assessed using Evaluation of the Diagnostic Assessment Research Tool (DART) Screener for DSM-5 Mood Disorder Module
- Total score of at least 20 on the 24-item Hamilton Depression Rating Scale (HDRS-24) at screening visit
- Treatment resistance to antidepressant pharmacotherapy during the current episode as indexed by Antidepressant Treatment History Form - Short Form (ATHF - SF). Specifically, participants will be required to have failed at least one or to have had an inadequate trial (including intolerance) to at least two antidepressants in the current episode
- Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.