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NCT05849402 · ClinicalTrials.gov registry record · NA
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
A NA study of Treatment-Resistant Depression and Bipolar II Disorder, Most Recent Episode Major Depressive, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05849402: Recruiting NA study of Treatment-Resistant Depression and Bipolar II Disorder, Most Recent Episode Major Depressive, sponsored by Stanford University.
NCT05849402 is a NA study of Treatment-Resistant Depression and Bipolar II Disorder, Most Recent Episode Major Depressive that is actively recruiting participants, run by Stanford University. The registered enrollment target is 60 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849402, a NA study of Treatment-Resistant Depression and Bipolar II Disorder, Most Recent Episode Major Depressive, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Conditions Studied
Interventions
- DEVICE Active Comparator: Active aiTBS
- DEVICE Sham Comparator: Sham aiTBS
Study Locations (1)
California
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2026-07-30 |
| Phase | NA |
What NCT05849402 shows while recruiting
NCT05849402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 2 interventions - of which Active Comparator: Active aiTBS is the first listed.
NCT05849402 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05849402 about?
NCT05849402 is a clinical study titled "Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder". 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-co...
What is the current status of trial NCT05849402?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2022-12-20. Estimated completion is 2026-07-30.
What conditions does trial NCT05849402 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression, Bipolar II Disorder, Most Recent Episode Major Depressive, Current Depressive Episode.
What interventions are being tested in trial NCT05849402?
The interventions under investigation include: Active Comparator: Active aiTBS (DEVICE), Sham Comparator: Sham aiTBS (DEVICE).
Who is sponsoring clinical trial NCT05849402?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849402 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05849402's enrollment target sits among peer trials
60 27th of 54 higher than 28 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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