Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT04982757
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04982757
Study Brief:
Protocol Section:
NCT04982757