Major Depressive Disorder Clinical Trial
Official title:
Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | January 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode. - Total HAMD17 score =20 and total MADRS score =20 before randomization. - Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. - Inadequate response to at least one antidepressant trial of adequate doses and duration. - A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization. - The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score = 7 points). - 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 spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, 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, and light therapy within 3 months; - Patients with serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; - 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; - 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 1 year; - First-degree relatives have bipolar affective disorder. - There is a significant risk of suicide (MADRS item 10 = 5). - Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators. - Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS). - Investigators think that was inappropriate to participate. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Changping Laboratory |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in MADRS | A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression | Baseline, Day 14(immediate post-treatment) | |
Secondary | change in MADRS | A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression | Baseline, Day 7, Day 14, Day 21 | |
Secondary | change in HAMD | A provider-administered questionnaire was used to assess remission and recovery from depression. The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing mood, guilt, general somatic symptoms, work and activities, anxiety, and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep, and insight items which are scored 0 to 2. On the HAMD-17 there can be a total score of 52. Higher scores represent higher depression severity | Baseline, Day 7, Day 14, Day 21 | |
Secondary | cognitive change in Digit Symbol Substitution Test (DSST) | Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page | Baseline, Day 14(immediate post-treatment) | |
Secondary | cognitive change in a continuous performance test (CPT) | CPT from the C-BCT measures a person's sustained and selective attention | Baseline, Day 14(immediate post-treatment) | |
Secondary | cognitive change in Trail-Making Test (TMT) | The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning | Baseline, Day 14(immediate post-treatment) | |
Secondary | cognitive change in Digit Span Test (DST) | DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span | Baseline, Day 14(immediate post-treatment) |
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