Intermittent Theta Burst Stimulation for Depression (iTBS Trial)

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a brain stimulation therapy called iTBS for people with severe depression. The therapy uses magnetic pulses to stimulate the brain and improve mood. Participants' progress will be monitored periodically. Intermittent theta-burst stimulation (iTBS) is a noninvasive brain stimulation treatment that has been approved by the U.S. Food and Drug Administration for treatment-resistant depression.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Open-labelExperimental Treatment1 Intervention

Theta burst stimulation (TBS) is a form of repetitive transcranial magnetic stimulation (TMS). Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session. Each treatment session thus involves \< 10 minutes of stimulation. The subject and researchers know what treatment is being administered.

Group II: Blinded ActiveActive Control1 Intervention

Standard TBS parameters consisting of 3-pulse, 50Hz bursts every 200 ms (5 Hz) at an intensity of 80% motor threshold (MT) will be utilized. Intermittent TBS will be delivered in 2-second trains of bursts repeated every 10 seconds for a total of 570 seconds (1800 pulses) in each session. Each treatment session thus involves \< 10 minutes of stimulation. The subject and researcher will not know what type of treatment will be administered.

Group III: Blinded ShamPlacebo Group1 Intervention

This is a sham treatment which will mimic the open-label and blinded active to enable the effects of the supposedly "active" treatment to be assessed objectively. The subject and researcher will not know what type of treatment will be administered. Each treatment session will be \< 10 minutes in duration.

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