Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05849402
Status
Recruiting
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Conditions

  • Bipolar II Disorder, Most Recent Episode Major Depressive
  • Current Depressive Episode
  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Comparator: Active aiTBS — DEVICE
    Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.
  • Sham Comparator: Sham aiTBS — DEVICE
    Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Study Details

The purpose of this study is to investigate the effectiveness of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) in inducing anti-depressant responses in individuals with treatment-resistant depression of bipolar II disorder. This is a double-blind, randomized, sham-controlled trial that targets a single location on the left dorsolateral prefrontal cortex (LDLPFC) using the MagPro rTMS system.

Key Dates

Start date
Dec 20, 2022
Status verified
Apr 2024
Primary completion
Jul 1, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active aiTBS
    Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.
  • Sham Comparator: Sham aiTBS
    Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Primary Outcome Measure

Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and immediately post-treatment, 1-month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Nick Bassano, MSW
[email protected]

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By research site
Stanford University· Palo Alto, CA

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