Condition: Depressive Symptoms · Depression, Anxiety · Psychological Distress · Sponsor: Ottawa Hospital Research Institute
Psychological and existential distress are a common cause of suffering among patients nearing the end of life, and a major reason for requesting medical aid in dying. Existing treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. There is a need to develop scalable, brief, and rapidly effective therapeutic approaches that can reduce psychological and existential distress in patients nearing the end of life. Repetitive Transcranial Magnetic Stimulation is an effective treatment for refractory depression, and new protocols and increasing availability of rTMS may make this therapy feasible and acceptable for patients who suffer from psychological or existential distress near the end of life. Among patients with advanced illness followed by a PC provider, the study objectives are to: 1. Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. 2. Test the feasibility and preliminary efficacy of rTMS for the treatment of psychological distress including: 1) ease of recruitment; 2) completion of follow-up; 3) effect size and variance estimates of treatment for primary and secondary outcomes; and 4) patient satisfaction with treatment. This study is a phase 2a dose-finding open-label clinical trial, followed by a phase 2b prospective, sham-control or sham-crossover study, depending on the therapeutic dose identified in p…
This description comes directly from the study's public registry record.
James Downar, MDCM, MHSc · 6135626262 · jdownar@toh.ca
Julie Lapenskie, MSc · 613-562-6262 · jlapenskie@bruyere.org
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| Elisabeth Bruyère Hospital | Ottawa, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04257227