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Intermittent Theta Burst Stimulation for MDD | Clinical Trials | Clareo Health

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Intermittent Theta Burst Stimulation for MDD

A Sham-controlled Study of Prefrontal Intermittent Theta Burst Stimulation in Major Depressive Disorder

NCT02506127•University of California, Los Angeles

Summary

This study will evaluate the effectiveness of intermittent Theta Burst Stimulation for patients with Major Depressive Disorder.

Detailed Description

The purpose of this research study is to evaluate the effectiveness and efficacy of intermittent Theta Burst Stimulation (iTBS) for treatment of Major Depressive Disorder (MDD). Subjects will be randomly assigned to two weeks (10 sessions) of treatment with open-label iTBS, blinded iTBS or blinded sham. 'Open-label' means that you (the subject) and the study staff will know that you are receiving active iTBS treatment. 'Blinded' or 'sham-controlled' means that you, the subject, will not know whether the treatment you receive is the active treatment or the non-active treatment. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating your brain. Subjects who do not show remission of symptoms after the first 2 weeks of treatment will receive 10 additional treatment sessions with open-label active iTBS. Subjects will be evaluated at Week 12 to assess the durability of symptoms changes.

Eligibility

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via the MINI structured interview
•2. Must have been on a stable dose of antidepressant medication (excluding tricyclic antidepressants) for at least 1 month prior to randomization, and with significant residual MDD symptoms as evidenced by a HamD17 score \> 17;
•3. If receiving medication other than for depression (e.g., anxiety, sleep, mood stabilization), must have been on stable dose for at least 1 month prior to randomization
•4. A history of treatment failure with at least one adequate trial of an antidepressant medication in the current episode, assessed by the Antidepressant Treatment and History Form
•5. Age range: 22-65.

Exclusion Criteria

•1. Patient is mentally or legally incapacitated, unable to give informed consent.
•2. Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); current Mini Mental State Examination ≤ 24; delirium or substance abuse within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
•3. Patients with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded.
•4. Patients with exposure to Electroconvulsive Therapy within the past 6 months, previous TMS treatment for any condition, or Vagus Nerve Stimulation treatment (lifetime).
•5. Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
•6. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, Cerebral Vascular Accident, or Transient Ischemic Attacks; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
•7. Any history of intracranial implant including cochlear implant, implanted electrodes/stimulators, aneursym clips or coils, stents, bullet fragments; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling.
•8. Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or with primary or secondary tumors in the Central Nervous System.
•9. current pregnancy, breast feeding, or not using a medically accepted means of contraception.
•10. Infection or loss of integrity of skin over the forehead, where the device will be positioned.
+2 more criteria

Locations (1)

UCLA TMS Clinic and Research Service

Los Angeles, California, United States

Key Dates

Start Date

December 9, 2017

Primary Completion Date

December 8, 2027

Completion Date

December 8, 2027

Last Updated

September 22, 2025

Enrollment

ESTIMATED participants

Conditions

Major Depressive Disorder

Interventions

Neuronetics XPLOR system

DEVICE

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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Major Depressive Disorder

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intermittent Theta Burst Stimulation for MDD

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression