Theta Burst Stimulation for Teenage Depression

(SAINT-KID Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sean J O'Sullivan, M.D., Ph. D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Must not be taking: Antidepressants, Ketamine, ECT

Disqualifiers: Pregnancy, Anxiety, Bipolar, Autism, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single-site open-label clinical trial of the Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) protocol. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS) and specifically as SAINT®-is effective as a first-line therapy in treating adolescents aged 14-19 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial. The main questions this trial aims to answer are: * Does SAINT® relieve symptoms of depression as a first-line therapy in adolescents? * Is SAINT® a feasible option as a first-line treatment for adolescent depression? Researchers will measure the depression symptoms in adolescent participants before and after SAINT®. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment. Adolescent participants will: * Remain antidepressant-free throughout the study period of 6-7 weeks. * Receive an MRI of their head for precision targeting * Receive 5 days of aiTBS (SAINT®)

Will I have to stop taking my current medications?

Yes, participants must remain antidepressant-free throughout the study, which means stopping any current antidepressant medications.

What data supports the effectiveness of the treatment Accelerated Intermittent Theta Burst Stimulation (SAINT®) for teenage depression?

Research shows that theta burst stimulation (TBS), a type of brain stimulation, has been effective in treating major depression in adults, with significant improvements in depression scores and higher response rates compared to a placebo. This suggests that similar treatments like SAINT® could potentially help with teenage depression as well. ^{1 2 3 4 5}

Is theta burst stimulation safe for teenagers?

Theta burst stimulation (TBS) has been studied mostly in adults, but some research has looked at its safety in children and teenagers. While there are still knowledge gaps, studies suggest that TBS is generally safe, though some participants may experience mild side effects. ^{5 6 7 8 9}

How is the treatment Accelerated Intermittent Theta Burst Stimulation (SAINT®) unique for teenage depression?

Accelerated Intermittent Theta Burst Stimulation (SAINT®) is unique because it is a noninvasive brain stimulation technique that delivers multiple sessions of magnetic pulses to the brain in a short period, potentially offering faster and more efficient relief from depression symptoms compared to traditional treatments. ^{1 5 10 11 12}

Research Team

Sean J O'Sullivan, M.D., Ph. D.

Principal Investigator

University of Texas at Austin

Eligibility Criteria

This trial is for teens aged 14-19 with their first major depressive episode, who haven't had a full depression treatment before and can stay off antidepressants. They must be in good health, agree to lifestyle rules during the study, and have ongoing psychiatric care.

Inclusion Criteria

I am between 14 and 19 years old.

I can read and understand English well enough to follow study instructions and communicate with the study team.

I am generally healthy aside from my current condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 days of aiTBS (SAINT®) with either 5 or 10 daily sessions

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in depressive symptoms at baseline and two follow-up visits

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Accelerated Intermittent Theta Burst Stimulation (SAINT®) (Neuromodulation Therapy)

Trial Overview The trial tests SAINT®, an accelerated form of TMS therapy called aiTBS, as a potential first-line treatment for adolescent depression. Over 5 days, participants receive targeted brain stimulation and are monitored for changes in depression symptoms.

Participant Groups

Group I: Truncated SAINT® Experimental Treatment 1 Intervention

5 daily sessions (25 total over 5-days) of SAINT® stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).

Group II: Standard SAINT® Active Control 1 Intervention

10 daily sessions (50 total over 5-days) of SAINT® stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dell Medical School at University of Texas at Austin Austin, TX

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Patients Recruited

86,100+

Magnus Medical

Industry Sponsor

Trials

5

Patients Recruited

1,100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsomedial prefrontal theta burst stimulation to treat anhedonia, avolition, and blunted affect in schizophrenia or depression - a randomized controlled trial. Bodén, R., Bengtsson, J., Thörnblom, E., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. Plewnia, C., Pasqualetti, P., Große, S., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of theta burst stimulation (TBS) for major depression: An exploratory meta-analysis of randomized and sham-controlled trials. Berlim, MT., McGirr, A., Rodrigues Dos Santos, N., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: a randomized placebo controlled trial. Prasser, J., Schecklmann, M., Poeppl, TB., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. Cai, DB., Qin, XD., Qin, ZJ., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Safety and Tolerability of Theta Burst Stimulation in Children and Adolescents. Elmaghraby, R., Sun, Q., Ozger, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. Richard, M., Noiseux, C., Desbeaumes Jodoin, V., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta-burst transcranial magnetic stimulation in children. Wu, SW., Shahana, N., Huddleston, DA., et al.[2012]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Theta Burst vs Repetitive Transcranial Magnetic Stimulation for the Treatment of Depression: A Meta-Analysis of Randomized Controlled Trials. Liu, C., Li, L., Li, B., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is accelerated, high-dose theta burst stimulation a panacea for treatment-resistant depression? Caulfield, KA.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated intermittent theta burst stimulation in major depression induces decreases in modularity: A connectome analysis. Caeyenberghs, K., Duprat, R., Leemans, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential bilateral accelerated theta burst stimulation in adolescents with suicidal ideation associated with major depressive disorder: Protocol for a randomized controlled trial. Yuruk, D., Ozger, C., Garzon, JF., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Dorsomedial prefrontal theta burst stimulation to treat anhedonia, avolition, and blunted affect in schizophrenia or depression - a randomized controlled trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of theta burst stimulation (TBS) for major depression: An exploratory meta-analysis of randomized and sham-controlled trials. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: a randomized placebo controlled trial. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Safety and Tolerability of Theta Burst Stimulation in Children and Adolescents. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta-burst transcranial magnetic stimulation in children. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Theta Burst vs Repetitive Transcranial Magnetic Stimulation for the Treatment of Depression: A Meta-Analysis of Randomized Controlled Trials. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Is accelerated, high-dose theta burst stimulation a panacea for treatment-resistant depression? [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Accelerated intermittent theta burst stimulation in major depression induces decreases in modularity: A connectome analysis. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Sequential bilateral accelerated theta burst stimulation in adolescents with suicidal ideation associated with major depressive disorder: Protocol for a randomized controlled trial. [2023]