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

March 28, 2023 updated by: Chen Qian
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial was divided into: screening period, pre-treatment period, treatment period (first session, second session) and follow-up period.

(1) Screening period (14 days before intervention to 2 days before intervention): 108 patients with mild to moderate adolescent depression, regardless of gender, are to be enrolled. Patients will sign an informed consent form and will complete the screening period from the 14th pre-intervention day to the 2nd pre-intervention day.

(2) Pre-treatment (1 day prior to intervention): Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will obtain a randomisation number 1 day prior to dosing and will be randomised in a 1:1:1 ratio to either the trial group (Group A), positive drug group (Group B) or blank control group (Group C). Subjects undergo an alcohol breath test and urine drug screen on an empty stomach at the test site to determine if they meet the entry criteria. Blood tests will be taken on an empty stomach on the day of the trial for testing, followed by food and 30 minutes later, blood pressure and EEG measurements will be taken and a depression scale will be completed after completion of NIR brain function measurements.

(3) Treatment period (first course: weeks 1 to 4, second course: weeks 5 to 8).

  1. Test group: Each subject was given a sufficient amount of CAVO aromatherapy patch + fluoxetine hydrochloride mimetic at a concentration of 3%. The subject was instructed to fix the aromatherapy patch on the near-nasal part of the mouthpiece daily and complete two sniffing inhalations at fixed times (07:45-08:00 and 19:45-20:00) daily during the course of the treatment period, each time for 15 minutes, and to take 1 tablet of fluoxetine mimetic orally once a day. times.
  2. Positive drug group: Each subject was given a sufficient amount of CAVO aromatherapy patch + fluoxetine hydrochloride tablet (20mg/tablet) at a concentration of 0.1%, and was instructed to take fluoxetine hydrochloride tablet (20mg/tablet) orally (10mg/dose, once a day). The aromatherapy patch was applied to the nasal area of the mask once a day.

  3. Blank control group: Subjects were given a sufficient amount of CAVO aromatherapy patch + fluoxetine hydrochloride mimetic (20mg/tablet) at a concentration of 0.1% and were instructed to fix the aromatherapy patch on the near nasal area of the mouthpiece twice a day during the treatment period at fixed times (07:45-08:00 and 19:45-20:00) and to take 1 tablet of fluoxetine mimetic by mouth for 15 minutes each time. tablet of fluoxetine mimetic (20mg/tablet), 10mg/dose, once a day.

    Subjects will be required to complete blood pressure measurements, EEG measurements and NIR brain function measurements at the end of the first and second sessions respectively and then complete a depression rating scale. Blood will also need to be taken on an empty stomach at the end of the treatment period for submission for testing.

  4. Follow-up period: (Week 9 to 10) Patients complete a follow-up examination at week 9 to 10 after the first dose. The investigator will continue to follow up with you by telephone for 1 week (at least 2 times, 1 day and 1 week after the end of the trial) to see how you are doing. You will be asked to answer a call back from your doctor and you will need to cooperate with the investigator's questioning.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • Yunnan Provincial Hospital of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
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
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.
Active Comparator: Positive drug group
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
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.
Sham Comparator: Blank control group
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
Placebo without drug treatment effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The score of Hamilton Depression Scale(HAMD),Children's Depression Inventory(CDI).
Time Frame: 3 months

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.
Time Frame: 3 months
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
Time Frame: 3 months
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.
Time Frame: 3 months
Serum glutamate in μmol/L, Gamma-aminobutyric acid in μmol/L, 5-hydroxytryptamine in μmol/L
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety indicators Safety indicators
Time Frame: 3 months
Heart rate in bpm,
3 months
Safety indicators Safety indicators
Time Frame: 3 months
blood pressure include systolic and diastolic pressure in mmHg
3 months
Physical examination indicators（Liver function and kidney function）
Time Frame: 3 months
Liver function include Alanine transaminase（ALT） in U/l; Aminotransferase aspartate（AST） in U/l;
3 months
Physical examination indicators（Liver function and kidney function）
Time Frame: 3 months
Alkaline phosphatase（ALP） in G/L; Albumin（ALB） in G/L; Globulin(GLB) in G/L;
3 months
Physical examination indicators（Liver function and kidney function）
Time Frame: 3 months
Total bilirubin（TBIL） in Umol/L;
3 months
Physical examination indicators（Liver function and kidney function）
Time Frame: 3 months
Kidney function include Blood Urea Nitrogen（BUN）in mmol/L；
3 months
Physical examination indicators（Liver function and kidney function）
Time Frame: 3 months
Creatinine(Cr）in μmol/（kg/d）.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Qian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAVO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

References to deidentified individual participant data (IPD) sets and supporting information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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