Depression Clinical Trial
Official title:
Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents
A randomized controlled trial was conducted to observe the improvement of mild to moderate depressive symptoms in children and adolescents with the aromatic herbal compound Cang Ai Volatile Oil (CAVO) and to evaluate the effectiveness and safety of the clinical application of CAVO.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | January 1, 2024 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | Inclusion Criteria: - Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and International Classification of Diseases (ICD) 10th Revision diagnostic criteria for mild to moderate depressive episodes, either first or recurrent, and not accompanied by psychotic symptoms. - Meeting the diagnostic criteria for depression in Chinese medicine. - 10 to 18 years of age (including borderline values), either sex. - Depression scale: BDI-2, HAMD depression scale score of mild to moderate - Healthy sense of smell, no allergic diseases or respiratory diseases. - Have not used antidepressants and other psychiatric drugs or physiotherapy such as electroconvulsive or transcranial magnetic stimulation for at least 1 week prior to the examination. - Depressive episodes lasting 2 weeks or more. - All subjects have volunteered to participate and signed an informed consent form, as approved by the hospital's ethics committee. Exclusion Criteria: - A history of alcohol and drug dependence is strictly excluded. - Current or prior diagnosis of a major psychiatric disorder other than depression consistent with DSM-5, such as bipolar disorder, neurodevelopmental disorder, neurocognitive disorder, schizophrenia, psychotic disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, antisocial personality disorder, etc. - Depression with a history of organic brain disease and endocrine disorders or secondary to other psychiatric disorders. - Persons at high risk of suicide: e.g., suicide attempts, recent suicide attempts, and those without family supervision - Those with a history of manic or hypomanic episodes. - Regularly taking antidepressants within 2 weeks prior to screening and not having discontinued psychotropic medication for 7 half-lives (at least 2 weeks for monoamine oxidase inhibitors and at least 1 month for fluoxetine) prior to randomisation to the group. - Patients who have received physical therapy such as MECT, TMS, Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), and other treatments such as light therapy, music therapy, exercise therapy, and acupuncture in the 3 months prior to screening. - Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine, haematological or other systemic disease which, in the opinion of the investigator, makes them unsuitable for enrollment in this study. - Persons with known hypersensitivity to the test drug, or who are allergic. - Those who have used the clinical trial drug within 3 months prior to the first dose, or those who plan to participate in other clinical trials during this study (ask, enquire). |
Country | Name | City | State |
---|---|---|---|
China | Yunnan Provincial Hospital of Traditional Chinese Medicine | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
Chen Qian |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The score of Hamilton Depression Scale(HAMD),Children's Depression Inventory(CDI). | The score of Hamilton Depression Scale(HAMD)>20,Total score 80 points,a total score of more than 35 on 24 items is considered severe depression, more than 20, possibly mild or moderate depression, and if less than 8, the patient has no depressive symptoms. The score of Children's Depression Inventory(CDI)>19,A scale of 0, 1 and 2 was used, indicating "occasionally", "often" and "always" respectively, indicating the frequency of symptoms, with a total score of 54. According to the original scale norm, 19 is the cut-off score for determining depressive symptoms, the higher the score the more severe the depression. |
3 months | |
Primary | Serum pro-inflammatory cytokine assays, anti-inflammatory cytokines. | Serum pro-inflammatory cytokine assays include Tumour necrosis factor-alpha in pg/mg; Interleukin-1ß in pg/mg; Interleukin-6 in pg/mg; Interferon gamma in pg/mg; Anti-inflammatory cytokines include Transforming growth factor-ß in pg/mg; Interleukin-10 in pg/mg; Interleukin-4 in pg/mg; Interleukin-8 in pg/mg | 3 months | |
Primary | HPA axis function test | Adrenocorticotropin-releasing hormone in µIU/ml; Pro-adrenocorticotropic hormone in µ IU/ml; Cortisol in µIU/ml | 3 months | |
Primary | Serum glutamate, gamma-aminobutyric acid, 5-hydroxytryptamine levels. | Serum glutamate in µmol/L, Gamma-aminobutyric acid in µmol/L, 5-hydroxytryptamine in µmol/L | 3 months | |
Secondary | Safety indicators Safety indicators | Heart rate in bpm, | 3 months | |
Secondary | Safety indicators Safety indicators | blood pressure include systolic and diastolic pressure in mmHg | 3 months | |
Secondary | Physical examination indicators(Liver function and kidney function) | Liver function include Alanine transaminase(ALT) in U/l; Aminotransferase aspartate(AST) in U/l; | 3 months | |
Secondary | Physical examination indicators(Liver function and kidney function) | Alkaline phosphatase(ALP) in G/L; Albumin(ALB) in G/L; Globulin(GLB) in G/L; | 3 months | |
Secondary | Physical examination indicators(Liver function and kidney function) | Total bilirubin(TBIL) in Umol/L; | 3 months | |
Secondary | Physical examination indicators(Liver function and kidney function) | Kidney function include Blood Urea Nitrogen(BUN)in mmol/L; | 3 months | |
Secondary | Physical examination indicators(Liver function and kidney function) | Creatinine(Cr)in µmol/(kg/d). | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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