Obsessive-Compulsive Disorder Clinical Trial
Official title:
Personalized Brain Functional Sectors (pBFS) Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder: A Randomized, Double-Blind, Sham-controlled Trial
The investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DLPFC for patients with treatment-resistant Obsessive-Compulsive Disorder.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 20, 2024 |
Est. primary completion date | July 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. - Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for obsessive-compulsive disorder, and currently experiencing a first or recurrence episode. - Total Y-BOCS score =20 and total HAMD score <17 before randomization. - Before randomization, patients must have received a minimum of 2 months of maintenance treatment with SSRI medication prior to randomization, or have undergone maintenance CBT treatment with inadequate response to SSRI medication (less than 50% symptom improvement), or have previously shown inadequate response (less than 50% symptom improvement) to at least one trial of SSRI medication or cognitive-behavioral therapy. Patients currently taking medication should have been on a stable dose for 8 weeks. - Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures. Exclusion Criteria: - Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, post-traumatic stress disorder, bipolar disorder, and secondary depression, etc.); - Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment; - History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold; - History of ECT, rTMS, light therapy within 3 months; - Patients with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher; - Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs. - Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding. - Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 6 months. - First-degree relatives have bipolar affective disorder and schizophrenia. - There is a significant risk of suicide (MADRS item 3 = 3). - Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators. - Patients in any clinical trials of other drugs or physical therapy ( DBS, ECT, rTMS) within 1 month before the screening - Investigators think that was inappropriate to participate. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Six Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Changping Laboratory |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | The Y-BOCS is a validated instrument stratifying the severity of obsessive episodes. This validated questionnaire was used to assess the response rate and remission rate of obsessive episodes. The response is defined as a symptom improvement of =35% on Y-BOCS; | Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment | |
Secondary | remission rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Remission was defined as a score <8. | Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment | |
Secondary | Partial response rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Partial response is defined as a symptom 35% = improvement =25% on Y-BOCS | Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment | |
Secondary | cognitive change in stroop | The Stroop test can be used to measure a person's selective attention capacity and skills, processing speed, and alongside other tests to evaluate overall executive processing abilities | Baseline, Day 15(immediate post-treatment) | |
Secondary | cognitive change in Hopkins verbal learning test(immediate recall) | The Hopkins Verbal Learning Test (HVLT-R) is one such assessment that consists of memorization of a list of words to test the ability to recall immediately after memorization | Baseline, Day 15(immediate post-treatment) | |
Secondary | cognitive change in Trail-Making Test | The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning | Baseline, Day 15(immediate post-treatment) |
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