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Transcranial Magnetic Stimulation
rTMS + Cognitive Therapy for Depression
N/A
Recruiting
Led By Sarah H Lisanby, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria -- HAM-D score greater than 17 and Item 1 score greater than or equal to 2. Alternatively: At the initial screening and beginning of Phase II, subjects must have a baseline score on the MADRS greater than or equal to 20 and YMRS of less than 12.
HAM-D score > 17 and Item 1 score greater than or equal to 2. Alternatively: At the initial screening and beginning of Phase II, subjects must have a baseline score on the MADRS >= 20 and YMRS of < 12
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after initiating intervention
Awards & highlights
Study Summary
This trial is testing whether combining MRI-guided transcranial magnetic stimulation (TMS) with talk therapy can help treat depression by finding the best area for TMS stimulation in each person and making the therapy more effective.
Who is the study for?
Adults aged 18-75 with major depressive disorder, who have not responded to at least one antidepressant or ECT (unless within the last year), and are on a stable medication dose for four weeks. Participants must understand the study, consent to it, commit to an intensive treatment schedule, use birth control if applicable, and have a depression severity score above set thresholds.Check my eligibility
What is being tested?
The trial is testing whether combining MRI-guided transcranial magnetic stimulation (TMS) with cognitive therapy improves depression symptoms more effectively than sham TMS plus cognitive therapy. It includes initial evaluations followed by six weeks of daily sessions and subsequent follow-ups over three months.See study design
What are the potential side effects?
Possible side effects include discomfort from wearing headgear during brain activity tests, reactions to electrical nerve stimulation like tingling or twitching, headaches from TMS sessions, and general unease in confined spaces due to MRI scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with major depression and my depression is severe.
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My depression is severe, and I'm not highly manic.
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I have been diagnosed with Major Depressive Disorder.
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I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after initiating intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after initiating intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in magnitude of Bold signal
Secondary outcome measures
Clinical Rating Scales: BSL, C-SSRS, CTQ, HAM-A, NIH-BFI, PANAS, RBANS, RRS, SHAPS, and TLEQ
Electrophysiological changes using MEG and EEG measures
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TMS+ Cognitive TherapyExperimental Treatment1 Intervention
active
Group II: Sham TMS + Cognitive TherapyPlacebo Group1 Intervention
inactive
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,786 Previous Clinical Trials
2,689,649 Total Patients Enrolled
666 Trials studying Depression
251,534 Patients Enrolled for Depression
Sarah H Lisanby, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
5 Previous Clinical Trials
404 Total Patients Enrolled
1 Trials studying Depression
35 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have anxiety or PTSD, but my main issue is depression.You have a higher chance of having seizures due to certain medical conditions or medications that make it more likely.You have had an allergic reaction to lidocaine before.I have been diagnosed with hearing loss by a doctor.I have received TMS treatment in the past.I have depression that didn't improve after trying at least one antidepressant or ECT, except if ECT was in the last year.My antidepressant dose has been stable for 4 weeks and will remain so during the study.I am not planning to start any new treatments, including therapy or antidepressants, during Phases I and II of the study.I have a serious or unstable health condition.My depression is severe, and I'm not highly manic.I have been diagnosed with major depression and my depression is severe.I have not had seizures, epilepsy, stroke, brain surgery, or significant head trauma.My current depressive episode has lasted more than 8 weeks but less than 5 years.I have a current diagnosis.You have been diagnosed with substance abuse or dependence (except for nicotine and caffeine) within the past 6 months.You have had an eating disorder within the past year or currently have an eating disorder.I have a condition like high blood pressure or diabetes, but it's controlled with medication.The investigator believes that you currently have a high risk of harming yourself or others.I have tested positive for COVID-19 or have symptoms of it.I can commit to the treatment schedule and attend all study visits.I have been diagnosed with Major Depressive Disorder.I haven't used any experimental drugs or devices in the last 4 weeks.I have a history of specific treatments.I am between 18 and 75 years old.I have experienced ringing in my ears.My depression is caused by another health issue or by substance use.I have never been diagnosed with bipolar, psychotic disorders, or major depression with psychosis.You have a long-term condition called obsessive-compulsive disorder (OCD).
Research Study Groups:
This trial has the following groups:- Group 1: Active TMS+ Cognitive Therapy
- Group 2: Sham TMS + Cognitive Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I sign up for this clinical research?
"This study is looking for 50 individuals who have major depressive disorder and are between 18-65 years old. Key inclusion criteria include: the current episode of depression lasting longer than 8 weeks, not exceeding a duration of 5 years, understanding of what is required in the trial as well as signing an informed consent, being a native English speaker, lack of response to at least one adequate antidepressant trial in the past (with certain exclusions), stable antidepressant dosage for 4 weeks prior to study entry if currently on medication, and meeting DSM-IV-TR criteria for primary diagnosis of MDD with a HAM-D score greater than 17 and Item 1 score"
Answered by AI
Might this study be inappropriate for patients over 30 years old?
"This clinical trial's eligibility requirements include an age range of 18 to 65 years old."
Answered by AI
Are there any patients you are still looking to enroll in this study?
"Correct. The clinicaltrials.gov website currently has an open call for volunteers for this trial. This particular study was originally posted on May 17th, 2018 and has since been updated on November 1st, 2022 in order to reflect changes 50 patients at 1 site are needed."
Answered by AI
How many people fit the requirements for this clinical trial?
"The clinical trial is presently seeking patients, with 50 slots open at 1 location. The study was originally posted on 5/17/2018 and was last updated on 11/1/2022, as indicated by the data available on clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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