Mood DisordersNCT06213220
Wearable Devices System Diagnoses Mood Disorder in Children and Adolescents
An observational study of Mood Disorders and Diagnosis, Psychiatric, run by Institute of Psychology, Chinese Academy of Sciences at 1 site in China.
Trial summary
As a diagnostic test, this study aims to explore the effectiveness of systems based on wearable devices in identifying mood disorders in children and adolescents. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Diagnosis, Psychiatric
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to Aug 2024
- Phase
- Observational
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children and adolescents mood disorders patients and healthy controls age between 6 - 16 boys and girls
Who may be able to join
- Subjects in the MDD group met the DSM-5 diagnostic criteria for MDD and those in the BD group met the DSM-5 criteria for BD
- able to cooperate to complete the study
- had signed the informed consent prior to the study
Who cannot join
- with severe physical illness
- demonstrated symptoms comorbid with other psychiatric disorders (e.g., schizophrenia, conduct disorder, personality disorder) and developmental disorders (e.g., autism spectrum disorder, intellectual impairment)
- other conditions deemed inappropriate for inclusion in the group
Trial locations and contacts
1 site in 1 country.
Zhengkui Liu, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Institute of Psychology, Chinese Academy of Sciences
Beijing
Fenghua Li, Ph.D, lifh@psych.ac.cn
About this study
Official title: A Diagnostic Test of Mood Disorder Recognition in Children and Adolescents Based on Wearable Devices
As a diagnostic test, this study aims to explore the effectiveness of systems based on wearable devices in identifying mood disorders in children and adolescents.
- Conditions
- Mood Disorders, Diagnosis, Psychiatric
- Medical subject headings
- Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mood disorders group | Participants are requested to wear the wristbands throughout the experiment, and upload their data every three days. Additionally, the Hamilton Depression Rating Scale (HAMD) and the Young Mania Rating Scale (YMRS) are administered once a week for measurement. | |
| healthy control group | Participants are requested to wear the wristbands throughout the experiment, and upload their data every three days. Additionally, the Hamilton Depression Rating Scale (HAMD) and the Young Mania Rating Scale (YMRS) are administered once a week for measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
R-R interval
the interval between heart beats derived from Photoplethysmography (PPG)
Measured: In the experiment conducted over a period of four weeks, the sampling frequency was 25Hz (based on seconds).The report will be available approximately one year after the end of the experiment.
Hamilton Depression Rating Scale (HAM-D)
Hamilton Depression Rating Scale (HAM-D) is the most widely used clinician-administered depression assessment scale. The original HAM-D has 21 items, but scoring is based only on the first 17. The patient is rated by a clinician on 17 items scored on a 5-point Likert-type scale. The total score ranges from 0 to 68. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Measured: In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.
Young Mania Rating Scale (YMRS)
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Here's a quick list of what each score range may indicate in a patient: Less than or equal to 12 = remission; 13 -19 = minimal symptoms; 20 - 25 = mild mania; 26 - 37 = moderate mania; 38 - 60 = severe mania
Measured: In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start3 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychology, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213220
- Sponsor's protocol ID
- E2KM011639-MDCA
- Status last verified
- Nov 2023
- First submitted
- 14 Dec 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Test of Mood Disorder Recognition in Children and Adolescents Based on Wearable Devices
- ClinicalTrials.gov ID
- NCT06213220
- Acronym / sponsor ID
- E2KM011639-MDCA
- Conditions
- Mood Disorders, Diagnosis, Psychiatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institute of Psychology, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Jan 2024 (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.
As a diagnostic test, this study aims to explore the effectiveness of systems based on wearable devices in identifying mood disorders in children and adolescents.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mood disorders group | – | –Participants are requested to wear the wristbands throughout the experiment, and upload their data every three days. Additionally, the Hamilton Depression Rating Scale (HAMD) and the Young Mania Rating Scale (YMRS) are administered once a week for measurement. |
| healthy control group | – | –Participants are requested to wear the wristbands throughout the experiment, and upload their data every three days. Additionally, the Hamilton Depression Rating Scale (HAMD) and the Young Mania Rating Scale (YMRS) are administered once a week for measurement. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children and adolescents mood disorders patients and healthy controls age between 6 - 16 boys and girls
Key inclusion criteria (3 listed)
- Subjects in the MDD group met the DSM-5 diagnostic criteria for MDD and those in the BD group met the DSM-5 criteria for BD
- able to cooperate to complete the study
- had signed the informed consent prior to the study
Key exclusion criteria (3 listed)
- with severe physical illness
- demonstrated symptoms comorbid with other psychiatric disorders (e.g., schizophrenia, conduct disorder, personality disorder) and developmental disorders (e.g., autism spectrum disorder, intellectual impairment)
- other conditions deemed inappropriate for inclusion in the group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
R-R interval
Time frame: In the experiment conducted over a period of four weeks, the sampling frequency was 25Hz (based on seconds).The report will be available approximately one year after the end of the experiment.
the interval between heart beats derived from Photoplethysmography (PPG)
Hamilton Depression Rating Scale (HAM-D)
Time frame: In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.
Hamilton Depression Rating Scale (HAM-D) is the most widely used clinician-administered depression assessment scale. The original HAM-D has 21 items, but scoring is based only on the first 17. The patient is rated by a clinician on 17 items scored on a 5-point Likert-type scale. The total score ranges from 0 to 68. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Young Mania Rating Scale (YMRS)
Time frame: In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Here's a quick list of what each score range may indicate in a patient: Less than or equal to 12 = remission; 13 -19 = minimal symptoms; 20 - 25 = mild mania; 26 - 37 = moderate mania; 38 - 60 = severe mania
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Zhengkui Liu, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Diagnosis, Psychiatric, run by Institute of Psychology, Chinese Academy of Sciences 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 3 inclusion and 3 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 1 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Fenghua Li, Ph.D (+86 13671258804, lifh@psych.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-R interval (time frame: In the experiment conducted over a period of four weeks, the sampling frequency was 25Hz (based on seconds).The report will be available approximately one year after the end of the experiment.). The study lists 3 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 1 Mar 2024.