Accelerated TMS for Depression and OCD

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jul 27, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating depression and obsessive-compulsive disorder (OCD) using a technique called repetitive transcranial magnetic stimulation (rTMS). This method involves using magnetic fields to stimulate specific areas of the brain, and the trial aims to see if an accelerated treatment plan over just 5 days can lead to quicker improvements in symptoms. Researchers will also use brain scans to identify markers that could help predict who will benefit most from this treatment and how to make it more effective.

To participate in this study, you should be diagnosed with either major depressive disorder or OCD and have experienced significant symptoms that haven't improved with standard treatments. Key eligibility criteria include being off antidepressants or on a stable dose for four weeks and having a certain level of severity in your symptoms. Participants will receive rTMS treatment for 10 hours a day over five days, and those who do not fully respond may receive additional treatment. This study is open to individuals aged 18 to 65, and it’s a great opportunity for those looking for new ways to manage their depression or OCD.

Gender

ALL

Eligibility 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

Trial Officials