Study on the Antidepressant Effects and Mechanism of Action of Cang-ai Volatile Oil Based on Near-Infrared Functional Brain Imaging and the NT-Trk Signalling Pathway

Dongdong Qin

Status: Completed

Conditions: Depression Disorder

Treatments: Drug: Bergamot Essential Oil; Drug: Cang-ai Volatile Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07384312

XS2022-015

Details and patient eligibility

About

This project plans to recruit 60 patients with depression, randomly assigning them to either the CAVO group or the bergamot essential oil group, with 30 participants in each. Quantitative measurement will be conducted using fNIRS technology to assess the impact of the intranasal CAVO pathway on brain functional connectivity during rest and brain activation during task performance. The antidepressant effects of CAVO will be evaluated using standardized depression scales, and target brain regions for CAVO's action will be identified through this process.

Enrollment: 60 patients

Sex: All

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion：

1. Meets the diagnostic criteria for depressive episodes as outlined in the fifth edition (revised) of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
2. Meets the diagnostic criteria for depression syndrome as defined in Part 1: Diseases of the Terminology for Clinical Diagnosis and Treatment in Traditional Chinese Medicine, issued by the National Administration of Traditional Chinese Medicine in 2023.
3. Scores on the 21-item Beck Depression Inventory (BDI) range from 10 to 15; scores on the 24-item Hamilton Depression Rating Scale (HAMD) range from 8 to 20.
4. Has a normal olfactory function, no history of allergic or respiratory diseases, aged 18-26 years.
5. At least one week prior to assessment, has not used antidepressants, other psychotropic medications, electroconvulsive therapy, or undergone transcranial magnetic stimulation or other physical therapies.
6. Exhibits depressive symptoms persisting for more than two weeks.
7. Right-handed.
8. Approved by the hospital ethics committee; all participants volunteer and have provided written informed consent.

Exclusion ：

1. Strict exclusion of individuals with a history of schizophrenia, alcohol dependence, or substance abuse.
2. Presence of organic brain disease, endocrine disorders, or depression secondary to other mental illnesses.
3. A score of ≥3 points on the suicidal item of the Hamilton Depression Rating Scale.
4. Pregnant or lactating women, or those with a history of manic or hypomanic episodes.
5. Family history of monomorphic or bipolar affective disorder.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CAVO group

Active Comparator group

Description:

The experimental group received CAVO inhalation therapy, with 0.05 ml (1 drop) of 10% Artemisia absinthium volatile oil dripped into the aroma diffusion capsule using a Pasteur pipette. The capsule was secured near the participant's nose on the mask with a magnet, and they were instructed to continue inhaling continuously for 1 hour daily.

Treatment:

Drug: Cang-ai Volatile Oil

BEO Group

Active Comparator group

Description:

The control group received BEO inhalation therapy, with one drop (0.05 ml) of 10% bergamot essential oil instilled into the aroma diffuser bottle using a Pasteur pipette. The diffuser was secured near the nasal area of the mask with a magnet, and participants were instructed to continuously sniff the aroma for one hour daily.

Treatment:

Drug: Bergamot Essential Oil