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New treatment option for Depression
Official title Accelerated TMS for Depression and OCD
ClinicalTrials.gov ID: NCT04982757
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Capacity to consent
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- Capacity to consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.