Parkinson's depression
Conditions
Interventions
Placebo group:Participants received placebo (co-formulated by the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (which has been licensed for the preparation of traditional
Experimental group:Participants received LBRD treatment daily for 4 consecutive weeks (150 ml of Chinese herbal decoction taken orally every day at 9-10 o clock in the morning and 150 ml of traditiona
Sponsors
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Male or female aged 35-80 years old; (2) Meet the clinical diagnostic criteria for Brain Parkinson's disease of the United Kingdom Parkinson's Disease Association and Hoehn-Yahr grade = 4; (3) Meet the diagnostic criteria for mild or moderate depressive episodes of the International Classification of Diseases (ICD-10) and the diagnostic criteria for insomnia of the International Classification of Disorders Third Edition (ICSD-3) and the symptoms of depression and insomnia have been comorbid for at least 4 weeks; (4) the patient's 17-item Hamilton Depression Rating Scale (HDRS-17) score ranged from 8 to 23 (range 0-52 higher scores indicate higher levels of depression); (5) Pittsburgh Sleep Quality Index (PSQI) greater than 5 (range 0-21 points higher scores indicate worse sleep quality and more sleep disturbances); (6) Meet the diagnostic criteria of "yin deficiency and internal heat" syndrome in traditional Chinese medicine; (7) Have not participated in other clinical trials within 3 months before the start of the study voluntarily participate in this study be able to sign the informed consent form and cooperate with the completion of Parkinson's disease symptom baseline collection and scale filling.
Exclusion criteria
Exclusion criteria: (1) Secondary depressive disorder and/or sleep disorder caused by organic disease medication or psychiatric disease; (2) Diagnosed with a major depressive episode according to ICD-10 criteria and showing suicidal ideation/attempt; (3) Depressive episodes in bipolar disorder or depressive syndromes caused by dysthymia reactive depression perimenopausal depression and other disorders; (4) comorbidities with other psychiatric and psychiatric disorders (e.g. generalized anxiety disorder obsessive-compulsive disorder etc.) or sleep-related disorders (e.g. obstructive sleep apnea syndrome restless legs syndrome etc.) diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V) and ICD-10 except for depressive episodes and insomnia; (5) Any serious physical disease serious cardiovascular or hematopoietic system disease or poor liver and kidney function; (6) history of alcohol abuse or drug dependence; (7) Female pregnancy or breastfeeding; (8) Taking medications (e.g. antidepressants hypnotics other psychotropic drugs Chinese herbal medicines etc.) and/or health care products (e.g. melatonin black cohosh etc.) or receiving other treatments (e.g. CBT mindfulness exercises magnetotherapy etc.) intended for the treatment of depression/insomnia within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 14-item Hamilton Anxiety Scale score;Interleukin-17;Cortisol;Serum ?-aminobutyric acid;17-item Hamilton Depression Rating Scale score;Cystatin-C;Dopamine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index score;Unified Parkinson's Disease Rating Scale score; | — |
Countries
China
Contacts
Public ContactSun Lingzhi
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed