Phase
Condition
Depression
Obsessive-compulsive Disorder
Treatment
MagVenture MagPro System with Brainsight neuronavigation device
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-Vcriteria)
Hamilton Depression Rating Scale score greater than or equal to 18 OR Yale-BrownObsessive-Compulsive Scale score greater than or equal to 16
Failed at least 1 prior trial of standard first-line treatment for depression or OCDper the modified Antidepressant Treatment History form and APA Practice Guidelines (e.g. serotonin reuptake inhibitor [SRI] or cognitive behavioral therapy withexposure and response prevention) OR had refused these treatments for individualreasons (e.g., cannot tolerate side effects, cannot tolerate exposure therapy,etc.).
Off antidepressants OR on a stable dose of antidepressants for greater than or equalto 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 aninhibitory effect on brain excitability (e.g., anticonvulsants, benzodiazepines, andatypical antipsychotics), or any other medications with relative hazard for use inTMS will be allowed upon review of medications and/or motor threshold determinationby TMS specialist.
Capacity to consent
Exclusion
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 forhis/her age and education)
Evidence of psychotic symptoms on diagnostic interview (interfering with capacity toconsent)
Have met criteria for any significant substance use disorder within the past 6months
Recent onset (within 8 weeks of screening) of psychotherapy
Prior completion of this accelerated TMS treatment protocol during the currentdepressive episode
Participated in any clinical trial with an investigational drug or device within thepast 6 weeks prior to screening
Evidence or history of significant neurological disorder including moderate-severehead trauma, stroke, Parkinson's disease or other movement disorder (except benignessential tremor), epilepsy
History of seizures (except juvenile febrile seizures) or any condition/concurrentmedication that could notably lower seizure threshold
Presence of foreign metal bodies/implanted intracranial devices (MRIcontraindication)
Current pregnancy or planning to conceive during the study
Abnormal bloodwork for electrolytes, thyroid or liver function
Study Design
Connect with a study center
Weill Cornell Medicine
New York, New York 10065
United StatesActive - Recruiting
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