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NCT05811104

Accelerated High-dose Sequential Bilateral Theta Burst Stimulation for Treatment Resistant Depression

Status unknown NA Last updated 13 April 2023
What this trial tests

NA trial testing Sequential bilateral theta burst stimulation in Treatment Resistant Depression in 40 participants. Status unknown.

Timeline
20 May 2023
Primary endpoint
20 May 2025
30 June 2025

Quick facts

Lead sponsorUniversity of Calgary
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment40
Start date20 May 2023
Primary completion20 May 2025
Estimated completion30 June 2025

Drugs / interventions tested

Conditions studied

Sponsor

University of Calgary

Who can join

Adults 18 to 65, any sex, with Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Repetitive transcranial magnetic stimulation (rTMS) and Theta burst stimulation (TBS) are approved by the US. Food and Drug administration (FDA) for the treatment of refractory major depression. TBS is more efficient than rTMS as it requires shorter stimulation time.Studies suggest that the efficacy of TBS could be enhanced and expedited by accelerated protocols (more than once daily sessions) with higher doses of stimulation (\>600 TBS pulses up to 3600 pulses per session) and shorter duration of treatment (4-10days). The main objective of this study is to determine the clinical efficacy and safety of accelerated high dose bilateral TBS treatment for patients with treatment resistant depression in comparison to sham stimulation using a randomized double blind clinical trial design.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Treatment Resistant Depression

Currently open trials in the same condition.

Other University of Calgary trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing