Depressive Disorder, Major Clinical Trial
Official title:
Therapeutic Effect of Accelerated Bilateral Repeated Transcranial Magnetic Stimulation on Geriatric Depression: a Prospective Double-blind, Randomized Controlled Trial
Verified date | May 2021 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the efficacy of accelerated bilateral repetitive transcranial magnetic stimulation (rTMS) on major depression, anxiety, cognitive function and physiological parameters in elderly depressive patients.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 21, 2022 |
Est. primary completion date | December 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - age between 60-85 years - literate and received basic education for at least 2 years - diagnosis of major depressive disorder, without psychotic features, according to DSM-5 - have a score of 20 or greater on the 17-item Hamilton Depression Rating Scale - failed to achieve clinical response by at least 1 antidepressant trial of sufficient dosage for at least 4 weeks - psychoactive agents were in stable doses before randomization Exclusion Criteria: - active suicide plans or attempts; or suicide attempts in the last 12 months - diagnosis of schizophrenia or bipolar disorder according to DSM-5 - have DSM-5-confirmed substance use disorder (excluding tobacco) in the last 3 months - have delirium, major neurocognitive disorder or MMSE < 24 - current use of bupropion >300 mg/day, tricyclic antidepressant, clozapine, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline or anti-epileptic agents excluding benzodiazepines - history of severe head trauma, epilepsy, multiple sclerosis, stroke, brain tumors, intracranial aneurysm, active intracranial infection, increased intracranial pressure, metallic implants in the brain, major brain surgery or major neurological diseases - with a cardiac pacemaker or defibrillator - received rTMS treatment before |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch | Douliu |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Taiwan University Hospital, Yun-Lin Branch |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of Change in 17-item Hamilton Depression Rating Scale (HAM-D 17) | HAM-D 17 is a scale rating the severity of depression, covering emotional, cognitive and somatic symptoms of depression. Higher scores indicate higher severity. Response to treatment is defined as = 50% decrease in HAM-D 17; remission is defined as = 7 points in HAM-D 17. | day 1, day 5, day 12, day 19 | |
Secondary | Degree of Change in Hamilton Anxiety Rating Scale (HAM-A) | HAM-A is a scale rating the severity of anxiety, covering emotional, cognitive and somatic symptoms of anxiety. Higher scores indicate higher severity. | day 1, day 5, day 12, day 19 | |
Secondary | Degree of Change in Mini-Mental State Examination (MMSE) | MMSE is a wildly-used tool to evaluate several cognitive function domains. | day 1, day 5, day 12, day 19 | |
Secondary | Degree of Change in Stroop Test | Task 1 (word phase) requests a subject to say a color name string (red, green, blue) printed in black; Task 2 (color phase) requests a subject to say the printed colors (red, green, blue) of letter "x" string; Task 3 (interference phase) requests a subject to say the printed colors of a string of color names (red, green, blue). | day 1, day 5, day 12, day 19 | |
Secondary | Degree of Change in Trail Making Test | Task 1 requests a subject to connect a sequence of 25 consecutive numbers regardless of their colors; Task 2 requires a subject to connect 25 consecutive numbers in alternative colors. | day 1, day 5, day 12, day 19 | |
Secondary | Degree of Change in Verbal Fluency Test | This test requests a subject to speak as many names of vegetables, fishes or fruit as possible in 45 seconds. | day 1, day 5, day 12, day 19 | |
Secondary | Degree of Change in Physiological Parameters | ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured. | day 1, day 5, day 12, day 19 |
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