DepressionEarly Phase 1NCT05789186
Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents
A Early Phase 1 study testing CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic, Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration and Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration in people with Depression, run by Chen Qian at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic, Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration and Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, 650032
Qian Chen, Master, 15896537050, 848236985@qq.com
About this study
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.
Read the 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).
- 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.
- 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.
- 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.
- 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.
- Conditions
- Depression
- Being tested
- CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic, Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration, Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration
- Keywords
- Depression, Children, Adolescents, Aromatic Chinese Medicine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimeticDrug
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.
Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentrationDrug
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.
Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentrationDrug
Placebo without drug treatment effect
| Study group | Role | What they receive |
|---|---|---|
| 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） Receives: 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) Receives: 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） Receives: Drug: Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
HPA axis function test
Adrenocorticotropin-releasing hormone in μIU/ml； Pro-adrenocorticotropic hormone in μ IU/ml； Cortisol in μIU/ml
Measured: 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
Measured: 3 months
Secondary outcomes (7)
Safety indicators Safety indicators
Heart rate in bpm,
Measured: 3 months
Safety indicators Safety indicators
blood pressure include systolic and diastolic pressure in mmHg
Measured: 3 months
Physical examination indicators（Liver function and kidney function）
Liver function include Alanine transaminase（ALT） in U/l; Aminotransferase aspartate（AST） in U/l;
Measured: 3 months
Physical examination indicators（Liver function and kidney function）
Alkaline phosphatase（ALP） in G/L; Albumin（ALB） in G/L; Globulin(GLB) in G/L;
Measured: 3 months
Physical examination indicators（Liver function and kidney function）
Total bilirubin（TBIL） in Umol/L;
Measured: 3 months
Physical examination indicators（Liver function and kidney function）
Kidney function include Blood Urea Nitrogen（BUN）in mmol/L；
Measured: 3 months
Physical examination indicators（Liver function and kidney function）
Creatinine(Cr）in μmol/（kg/d）.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Qian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Qian, Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789186
- Sponsor's protocol ID
- CAVO
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: References to deidentified individual participant data (IPD) sets and supporting information.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05789186
- Acronym / sponsor ID
- CAVO
- Conditions
- Depression
- Keywords
- Depression, Children, Adolescents, Aromatic Chinese Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chen QianUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimeticCAVO aromatherapy patch at 3% concentration （continue sniffing for 15 minutes ）and Fluoxetine Hydrochloride mimetic （20mg/tablet，once a day，10mg each time） |
| Positive drug group | Active comparator | Drug: Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentrationCAVO aromatherapy patch at 0.1% concentration（continue sniffing for 15 minutes ） and Fluoxetine hydrochloride tablet （20mg/tablet，once a day，10mg each time) |
| Blank control group | Sham comparator | Drug: Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentrationConcentration 0.1% CAVO aromatherapy patch（continue sniffing for 15 minutes）and fluoxetine hydrochloride mimetic（20mg/tablet，once a day，10mg each time） |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimeticCAVO 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. | Drug | Test group |
| Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentrationFluoxetine 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. | Drug | Positive drug group |
| Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentrationPlacebo without drug treatment effect | Drug | Blank control group |
Primary outcome
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.
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
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
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
7 secondary outcomes
Safety indicators Safety indicators
Time frame: 3 months
Safety indicators Safety indicators
Time frame: 3 months
Physical examination indicators（Liver function and kidney function）
Time frame: 3 months
Physical examination indicators（Liver function and kidney function）
Time frame: 3 months
Physical examination indicators（Liver function and kidney function）
Time frame: 3 months
Physical examination indicators（Liver function and kidney function）
Time frame: 3 months
Physical examination indicators（Liver function and kidney function）
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No. References to deidentified individual participant data (IPD) sets and supporting information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic, Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration and Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration in people with Depression, run by Chen Qian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Chen, Mater (15896537050, 848236985@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of Hamilton Depression Scale(HAMD),Children's Depression Inventory(CDI). (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.