Major Depressive Disorder Clinical Trial
Official title:
Personalized Brain Functional Sectors(pBFS) Guided 20min Inter-session Interval rTMS Treatment for Major Depressive Disorder: a Randomized, Double-Blind, Sham-controlled Trial
The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | August 30, 2024 |
Est. primary completion date | July 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 the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes. - Hospitalized patients aged 18-65 years (inclusive), male or female. - Total HAMD-17 score =20 before randomization.Total MADRS score =25 before randomization. - 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. - Voluntarily participate in the trial and sign informed consent. Exclusion Criteria: - Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on); - 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 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 heart, liver, kidney diseases, diabetes, and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; - The female of childbearing potential plans to become pregnant during the trial, and the female who is pregnant or breastfeeding. - Alcohol abuse or drugs abuse 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 and Day 21(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, 2-week post-treatment, 4-week post-treatment | |
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, 2-week post-treatment, 4-week post-treatment | |
Secondary | change in QID_SR | A provider-administered questionnaire was used to assess remission and recovery from depression. The 16-item QIDS_SR is a widely used self-report instrument covering depressive symptoms incorporating nine Diagnostic and Statistical Manual of Mental Disorder-IV (DSM-IV) diagnostic criteria for major depressive disorders. Each item is scored on a scale of 0 to 4. Higher scores represent higher depression severity. | Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment | |
Secondary | change in HAMA | The HAMA was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). | Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment |
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