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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chen Qian
• Treatments: Fluoxetine

Criteria

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).