Actively Recruiting
pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression
Led by Changping Laboratory · Updated on 2024-05-07
270
Participants Needed
5
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression.
CONDITIONS
Official Title
pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with depression per DSM-5 without psychiatric symptoms, including single or repeated episodes
- Hamilton Depression Scale (17 items) score of 20 or higher before randomization
- Montgomery Asberg Depression Rating Scale score of 20 or higher before randomization
- Age between 18 and 65 years, any gender
- At least one antidepressant used for 6 weeks at or above prescribed dosage
- Moderate or higher treatment resistance assessed by Maudsley Staging Method with score of 7 or more
- Stable antidepressant regimen for at least 4 weeks before randomization at prescribed dosage or higher
- Minimum of 5 years of education
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Diagnosis of other mental disorders including schizophrenia spectrum, bipolar, neurodevelopmental, neurocognitive disorders, or depression due to substances, drugs, or medical conditions
- Presence of pacemakers, cochlear implants, metal foreign objects, implanted electronic devices, or contraindications to MRI or rTMS
- History of epilepsy with at least 2 unprovoked seizures more than 24 hours apart, epilepsy syndrome, or seizures within past 12 months
- Treatment with modified electroconvulsive therapy, rTMS, or light therapy within past 3 months
- Organic brain diseases such as stroke, brain tumors, or severe brain injury history
- Serious heart, liver, kidney diseases, diabetes, or other serious physical illnesses
- Pregnant, breastfeeding, or planning pregnancy during the trial period
- History of drug or alcohol abuse in the past year
- First-degree relative with bipolar disorder
- Significant suicide risk (MADRS item 10 score of 5 or higher)
- Severe communication difficulties preventing normal cooperation
- Current participation in other clinical trials with drugs or physical therapies like DBS, ECT, or rTMS
- Investigator judgment deeming participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hebei Mental Health Center
Hebei, Baoding, China
Actively Recruiting
2
West China Hospital, Sichuan University
Chengdu, China
Not Yet Recruiting
3
Inner Mongolia Mental Health Center
Hohhot, China
Actively Recruiting
4
Shandong Daizhuang Hospital
Jining, China
Not Yet Recruiting
5
The Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Actively Recruiting
Research Team
M
Meiling Li, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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