Major Depressive Disorder Clinical Trial
Official title:
Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients
Verified date | July 2020 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The teaching platform of the TCM daycare clinics for depression patients will provide a good clinical training environment for the trainees. They can learn how to take care of depression patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors.
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of depression according to DSM-IV (Diagnosis code: 296.21-296.30, 300.4) 2. Age 18-65 years, male or female 3. Evaluation of the 21-item Hamilton Rating Scale for Depression (HAMD) 8 points or more 4. Fully understand the entire research plan and sign the informed consent form (aged 18-20 years old must be jointly signed by a legal agent) Exclusion Criteria: 1. Have a diagnosis of mental illness other than depression in the last or past 6 months, including unipolar major depression, including dyslexia, organic mental disorder, impulse control disorder, substance use disorder, bipolar mental disorder or substance abuse. 2. Medical history of patients diagnosed with borderline, antisocial personality disorder 3. Take anti-psychotic disorders and anti-epileptic drugs in the past six months. 4. Have or may become pregnant 5. A person with serious suicidal ideation or suicide attempt who must be hospitalized for close monitoring |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Acupuncture, China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale, HAM-D | Each question of HAM-D is rated 3-5 points, eight questions are 0-2 points, nine questions are 0-4 points, and the total score is 0-52 points. Evaluate the emotional and physical and mental states observed in the case during the most recent week and interview. | Start of treatment (day 0) and end of treatment (week 8) | |
Primary | Beck Depression Inventory(BDI) | Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference | Start of treatment (day 0) and end of treatment (week 8) | |
Primary | Pittsburgh Sleep Quality Inventory | It is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, and is also suitable for the evaluation of sleep quality in ordinary people. | Start of treatment (day 0) and end of treatment (week 8) | |
Primary | WHOQOL-Taiwan | Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief; | Start of treatment (day 0) and end of treatment (week 8) |
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