Testing a new brain stimulation treatment for depression and other psychiatric disorders
Testing a Transdiagnostic TMS Treatment Target
This study is testing a new brain stimulation treatment for people with major depression and another psychiatric disorder to see if it can help improve their symptoms and brain function.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06282146 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a novel brain stimulation technique called accelerated intermittent theta burst stimulation, targeting the posterior parietal cortex in individuals suffering from major depressive disorder along with at least one additional psychiatric disorder. The study will assess the safety profile of this non-invasive treatment and investigate its effects on symptoms of depression and other psychiatric conditions, as well as its impact on brain function. By focusing on the shared brain network across multiple disorders, this approach seeks to improve treatment outcomes for patients with complex psychiatric profiles.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a diagnosis of major depressive disorder and at least one additional psychiatric condition.
Not a fit: Patients with only one psychiatric disorder or those who do not meet the criteria for major depressive disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective intervention for patients with multiple psychiatric disorders, potentially improving their overall mental health and quality of life.
How similar studies have performed: While the approach of targeting shared brain networks across psychiatric disorders is innovative, previous studies have shown promise in using transcranial magnetic stimulation for individual disorders, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 * English proficiency sufficient for informed consent, questionnaires/tasks, and treatment * Diagnosis of MDD per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders) and currently experiencing a moderate to severe episode: * \>20 on Beck Depression Inventory (BDI) * \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 14, 15 * Moderate to severe level of treatment resistance (Maudsley Staging Method)16, 17 * Diagnosis of at least one or more of the following psychiatric conditions per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders): * Generalized anxiety disorder (GAD), panic disorder (PD), or social anxiety disorder (SAD) * Obsessive compulsive disorder (OCD) * Post-traumatic stress disorder (PTSD) * Physician referral for individuals with either schizophrenia or schizoaffective disorder * Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit * Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial * Agreement to lifestyle considerations * Abstain from becoming pregnant from time of screening to two weeks after treatment (post-treatment MRI visit) * Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment * Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and each TMS session Exclusion Criteria: * Active pregnancy as determined by a urine pregnancy test * Positive urine drug screen for illicit substances (not including THC) * Depressive symptoms refractory to 8 sessions of electroconvulsive therapy (ECT) * Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT) * Receiving or planning to receive other TMS treatments during course of participation * History of * Autism spectrum disorder * Neurosurgical intervention for depression * Intellectual disability * Severe cognitive impairment * Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion) * Untreated or insufficiently treated endocrine disorder * Treatment with investigational drug or intervention during the study period * Depth-adjusted TMS treatment dose \> 65% maximum stimulator output * Existing tinnitus (ringing in the ears) * Current evidence of: * Mania or hypomania * Active suicidal ideation or a suicide attempt (defined by C-SSRS) within the past year * Neurological lesion * Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.). * Moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal (not including cannabis or nicotine use disorders) * Bipolar I disorder * For participants with schizophrenia or schizoaffective disorder referred by a physician: * Total PANSS score \>90 * Score \>4 (moderate-severe) on any positive PANSS item * Active substance use disorder (other than nicotine) * Hospitalization for psychosis in the past 6 months * Severe borderline personality disorder * Any other condition deemed by the PI to interfere with the study or increase risk to the participant
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Joseph J Taylor, MD, PhD — Brigham and Women's Hospital
- Study coordinator: Lauren Sanderson
- Email: bwht5@bwh.harvard.edu
- Phone: 617-525-3536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.