No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Who this trial is looking for
This trial is looking for people with depression or OCD to test a new treatment method. Participants will receive repetitive transcranial magnetic stimulation (rTMS) for five days to help improve their symptoms.
Are You a Good Fit for This Trial?
Rules you outSeizuresModerate-severe head traumaStrokeParkinson's diseaseEpilepsy
You may be able to join if
I have been diagnosed with major depressive disorder or OCD.
I have a Hamilton Depression Rating Scale score of 18 or higher or a Yale-Brown Obsessive-Compulsive Scale score of 16 or higher.
I have tried at least one standard treatment for depression or OCD without success or I have refused these treatments for personal reasons.
I have not taken antidepressants for at least four weeks or I am on a stable dose of antidepressants.
I can give my consent to participate.
You may not be able to join if
I am at imminent risk of suicide.
I have other serious psychiatric disorders beyond OCD and major depression.
I have signs of cognitive impairment.
I have psychotic symptoms that interfere with my ability to consent.
I have a significant substance use disorder in the past six months.
I have started psychotherapy within the last 8 weeks.
I have had this accelerated TMS treatment during my current depressive episode.
I have a history of significant neurological disorders or head trauma.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD.
A second goal of this study i…
Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD.
A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity.
Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area.
The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.
Trial Locations
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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 …
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
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