Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents

NCT05789186 | Unknown Early Phase 1

• 1 other identifier: CAVO
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Children; Adolescents; Aromatic Chinese Medicine

Outcome Measures

Primary Outcomes (4)

• 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

• Serum pro-inflammatory cytokine assays, anti-inflammatory cytokines.

  Serum pro-inflammatory cytokine assays include Tumour necrosis factor-alpha in pg/mg; Interleukin-1β in pg/mg; Interleukin-6 in pg/mg; Interferon gamma in pg/mg; Anti-inflammatory cytokines include Transforming growth factor-β in pg/mg; Interleukin-10 in pg/mg; Interleukin-4 in pg/mg; Interleukin-8 in pg/mg

  3 months

• HPA axis function test

  Adrenocorticotropin-releasing hormone in μIU/ml； Pro-adrenocorticotropic hormone in μ IU/ml； Cortisol in μIU/ml

  3 months

• 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 Outcomes (7)

• Safety indicators Safety indicators

  3 months

• Safety indicators Safety indicators

  3 months

• Physical examination indicators（Liver function and kidney function）

  3 months

• Physical examination indicators（Liver function and kidney function）

  3 months

• Physical examination indicators（Liver function and kidney function）

  3 months

Study Arms (3)

Test group

EXPERIMENTAL

CAVO aromatherapy patch at 3% concentration （continue sniffing for 15 minutes ）and Fluoxetine Hydrochloride mimetic （20mg/tablet，once a day，10mg each time）

Drug: CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic

Positive drug group

ACTIVE COMPARATOR

CAVO aromatherapy patch at 0.1% concentration（continue sniffing for 15 minutes ） and Fluoxetine hydrochloride tablet （20mg/tablet，once a day，10mg each time)

Drug: Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration

Blank control group

SHAM COMPARATOR

Concentration 0.1% CAVO aromatherapy patch（continue sniffing for 15 minutes）and fluoxetine hydrochloride mimetic（20mg/tablet，once a day，10mg each time）

Drug: Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration

Interventions

CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic DRUG

CAVO aromatherapy patch at 3% concentration enhances neuroelectrical activity in the brain (especially in the prefrontal cortex), exerting an antidepressant effect.Fluoxetine hydrochloride mimetic without drug treatment effect.

Test group

Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration DRUG

Fluoxetine hydrochloride tablet was widely used selective 5-HT reuptake inhibitor (SSRI) that selectively inhibits the 5-HT transporter, blocks the reuptake of 5-HT by the presynaptic membrane, and prolongs and increases the effects of 5-HT, resulting in antidepressant effects.CAVO aromatherapy patch at 0.1% concentration without drug treatment effect.

Positive drug group

Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration DRUG

Placebo without drug treatment effect

Blank control group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chen Qian: lead

Study Sites (1)

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Qian Chen, Mater

CONTACT

15896537050; 848236985@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yunnan University of Chinese Medicine

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 29, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)