Accelerated TMS treatment for depression and OCD
Accelerated TMS for Depression and OCD
This study is testing a fast-acting brain treatment for depression and OCD to see if it can help people feel better by focusing on specific areas of the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04982757 on ClinicalTrials.gov |
What this trial studies
This study investigates an accelerated protocol of repetitive transcranial magnetic stimulation (rTMS) over five days to treat symptoms of depression and obsessive-compulsive disorder (OCD). Participants will undergo clinical assessments and functional magnetic resonance imaging (fMRI) scans to identify biomarkers and predict treatment outcomes. The study aims to optimize rTMS treatment by targeting specific areas of the brain, such as the lateral prefrontal cortex and dorsomedial prefrontal cortex. By comparing these targets, the research seeks to enhance the effectiveness of rTMS for individuals with these mental health conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with major depressive disorder or OCD who have not responded to standard first-line treatments.
Not a fit: Patients who have not been diagnosed with depression or OCD, or those who have not failed prior treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients suffering from depression and OCD.
How similar studies have performed: Other studies have shown promise with rTMS for depression and OCD, but this accelerated approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-V criteria) * Hamilton Depression Rating Scale score greater than or equal to 18 OR Yale-Brown Obsessive-Compulsive Scale score greater than or equal to 16 * Failed at least 1 prior trial of standard first-line treatment for depression or OCD per the modified Antidepressant Treatment History form and APA Practice Guidelines (e.g. serotonin reuptake inhibitor \[SRI\] or cognitive behavioral therapy with exposure and response prevention) OR had refused these treatments for individual reasons (e.g., cannot tolerate side effects, cannot tolerate exposure therapy, etc.). * Off antidepressants OR on a stable dose of antidepressants for greater than or equal to four weeks with plans to remain on this stable dose during the study Note: Medications that are known to increase cortical excitability (e.g., buprorion, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., anticonvulsants, benzodiazepines, and atypical antipsychotics), or any other medications with relative hazard for use in TMS will be allowed upon review of medications and/or motor threshold determination by TMS specialist. * Capacity to consent Exclusion Criteria: * Imminent risk of suicide (based on the CSSRS) * Presence of primary psychiatric diagnoses other than OCD, MDD and/or co-morbid GAD (ex. PTSD, MDD with psychotic features, primary psychotic illness, Bipolar I or II) * Evidence of cognitive impairment (MMSE score falling 1 SD below mean score for his/her age and education) * Evidence of psychotic symptoms on diagnostic interview (interfering with capacity to consent) * Have met criteria for any significant substance use disorder within the past 6 months * Recent onset (within 8 weeks of screening) of psychotherapy * Prior completion of this accelerated TMS treatment protocol during the current depressive episode * Participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening * Evidence or history of significant neurological disorder including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor), epilepsy * History of seizures (except juvenile febrile seizures) or any condition/concurrent medication that could notably lower seizure threshold * Presence of foreign metal bodies/implanted intracranial devices (MRI contraindication) * Current pregnancy or planning to conceive during the study * Abnormal bloodwork for electrolytes, thyroid or liver function
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Conor Liston, MD, PhD — Weill Medical College of Cornell University
- Study coordinator: Megan Johnson
- Email: tmsinfo@med.cornell.edu
- Phone: 646-962-2900
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.