Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06323486

Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression — CogniTReaD  

Depressive Disorder, Treatment-Resistant Clinical Trial

Official title:
Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost, Depression, Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression: A Randomized, Double-blind, Sham-controlled Trial

Clinical Trial Summary

The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future.

Clinical Trial Description

The CogniTReaD study is a two-arm, sham-controlled, double-blinded, treatment-sequenced, randomized clinical trial that will evaluate and explore the effects and safety of accelerated bilateral sequential theta burst stimulation (absTBS) compared to sham control in terms of improving dual-task cost, cognitive functions, depression, other outcomes (anxiety, health-related quality of life, activities of daily living, global impression, and other gait performance), and occurrence of adverse events (AE) measured at Week 2 (i.e., posttreatment acute effects) in older adults with treatment-resistant depression (TRD). We shall also evaluate the effects and safety of absTBS on improving dual-task cost, cognitive functions, depression and occurrence of AE in terms of AE occurrences measured at Week 6, Week 8, and Week 10 (i.e., posttreatment delayed effects) in older adults with TRD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06323486
Study type Interventional
Source Ontario Shores Centre for Mental Health Sciences
Contact Amer M. Burhan, MBChB, MSc
Phone 905.430.4055
Email burhana@ontarioshores.ca
Status Recruiting
Phase N/A
Start date April 1, 2024
Completion date March 30, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03851380 - Improving Brain Stimulation Through Imaging
Completed NCT04977674 - Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine Early Phase 1
Completed NCT03207282 - Treatment Resistant Depression in America Latina
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT02691520 - Epidemiology of Treatment Resistant Depression in Taiwan Phase 4
Active, not recruiting NCT04159012 - NESBID: Neuro-Stimulation of the Brain in Depression N/A
Recruiting NCT05870501 - Synaptic Imaging and Network Activity in Treatment Resistant Depression N/A
Completed NCT04239651 - rTMS With and Without iCBT For the Treatment of Resistant Depression (TRD) N/A
Completed NCT02493868 - A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression Phase 3
Completed NCT04599855 - A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression Phase 4
Completed NCT03283670 - Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies Phase 2
Recruiting NCT03004521 - Lithium Versus Quetiapine in Treatment Resistant Depression Phase 4
Recruiting NCT04783103 - Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study N/A
Completed NCT03434041 - A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression Phase 3
Terminated NCT03887624 - Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression. Early Phase 1
Completed NCT02577250 - Ketamine Infusions for PTSD and Treatment-Resistant Depression Phase 1
Recruiting NCT02610712 - Clinical Trial of the Use of Ketamine in Treatment Resistant Depression Phase 4
Completed NCT03051256 - Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD Phase 2
Enrolling by invitation NCT05581797 - Psilocybin-assisted Interpersonal Therapy for Depression N/A
Completed NCT02782104 - A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression Phase 3