Depression - Major Depressive DisorderNCT06594588
Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression
A study testing Aerobic exercise in people with Depression - Major Depressive Disorder, run by Peking University at 1 site in China.
Trial summary
The goal of this project is to quantify the relative effectiveness of aerobic exercise monitored by smart wristbands in assisting the treatment of depression and improving cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-45 years (including 18 and 45), no gender restriction;
- Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
- Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 14; Mood Disorder Questionnaire (MDQ) screening negative to exclude bipolar disorder patients; and Clinical Global Impressions-Severity (CGI-S) score ≥ 4;
- Maintained on antidepressant treatment for at least 4 weeks or not using antidepressant treatment;
- Written informed consent obtained from the patient.
Who cannot join
- Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
- Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;
- Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury;
- Suffering from conditions with high exercise risk, such as hypertension or heart disease;
- Currently undergoing systematic psychological therapy;
- In the 3-minute step test, males with a recovery heart rate more than131 and females with a recovery heart rate more than 140;
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- Physically restricted individuals unable to participate in physical exercise;
- Physical Activity Readiness Questionnaire (PAR-Q) score ≥ 2;
- Pregnant women or individuals with contraindications to MRI examinations;
- Individuals with severe suicidal tendencies or at risk of harming others.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hostipal
Beijing, Beijing Municipality, 100191
Weihua Yue, Doctor, 010-82805307, dryue@bjmu.edu.cn
About this study
Official title: Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression Monitored by Smart Band: a Randomized Controlled Trial
The goal of this project is to quantify the relative effectiveness of aerobic exercise monitored by smart wristbands in assisting the treatment of depression and improving cognitive function. It aims to explore the mechanisms through which aerobic exercise exerts its effects using imaging genetics and other methods, and to identify suitable populations for exercise, ultimately providing personalized clinical exercise prescriptions. This study will intervene from a behavioral perspective and also seeks to motivate participants to change and improve their physical activity habits.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Aerobic exercise
- Keywords
- Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Moderate-intensity aerobic exercise for 30-50 minutes three times a week was added to usual medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Experimental | Aerobic exercise intervention combined with conventional drug treatment Receives: Behavioral: Aerobic exercise |
| Waiting control group | No intervention | Antidepressants were routinely used and aerobic exercise interventions were performed at the end of the 8-week follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Rating Scale (HAMD)
The outcome is assessed by HAMD-17 Scale.
Measured: Week 4 and 8 of treatment duration
Secondary outcomes (15)
Change from baseline in THINC-it score
Measured: Week 4 and 8 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: Week 4 and 8 of treatment duration
Response to treatment
The reduction rate of HAMD-17 or MADRS score was ≥50%
Measured: Week 4 and 8 of treatment duration
Clinical Global Impression-Severity of Illness (CGI-S)
Measured: Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)
Measured: Week 4 and 8 of treatment duration
Change from baseline in Ruminative Responses Scale (RRS)
Measured: Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
Measured: Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)
Measured: Week 4 and 8 of treatment duration
Rating Scale for Side Effects (SERS) -Antidepressant
Rating Scale for Side Effects (SERS) -Antidepressant
Measured: Week 4 and 8 of treatment duration
Mood Disorder Questionnaire (MDQ)
Measured: Week 4 and 8 of treatment duration
International Physical Activity Questionnaire (IPAQ)
Measured: Week 4 and 8 of treatment duration
Biomarkers level
CRP, IL-1β, TNF-α, IL-6, IL-8, IL-10 and other immune factors, irisin, neurotrophic factor BDNF, vascular endothelial growth factor VEGF, and insulin growth factor IGF-1, NLRP3, CXCL8, CXCL3, CCL5, etc
Measured: Week 0 and 8 of treatment duration
Body weight in kilograms
Measured: Week 4 and 8 of treatment duration
Body fat rate
Measured: Week 4 and 8 of treatment duration
Brain imaging features
Acquisition was performed by magnetic resonance imaging
Measured: Week 0 and 8 of treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Sep 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Yue, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594588
- Sponsor's protocol ID
- 2024-11
- Status last verified
- Jul 2025
- First submitted
- 5 Sep 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression Monitored by Smart Band: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06594588
- Acronym / sponsor ID
- 2024-11
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 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.
The goal of this project is to quantify the relative effectiveness of aerobic exercise monitored by smart wristbands in assisting the treatment of depression and improving cognitive function. It aims to explore the mechanisms through which aerobic exercise exerts its effects using imaging genetics and other methods, and to identify suitable populations for exercise, ultimately providing personalized clinical exercise prescriptions. This study will intervene from a behavioral perspective and also seeks to motivate participants to change and improve their physical activity habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Experimental | Behavioral: Aerobic exerciseAerobic exercise intervention combined with conventional drug treatment |
| Waiting control group | No intervention | –Antidepressants were routinely used and aerobic exercise interventions were performed at the end of the 8-week follow-up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-45 years (including 18 and 45), no gender restriction;
- Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
- Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 14; Mood Disorder Questionnaire (MDQ) screening negative to exclude bipolar disorder patients; and Clinical Global Impressions-Severity (CGI-S) score ≥ 4;
- Maintained on antidepressant treatment for at least 4 weeks or not using antidepressant treatment;
- Written informed consent obtained from the patient.
Key exclusion criteria (10 listed)
- Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
- Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;
- Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson's disease, epilepsy, etc.) and a history of severe traumatic brain injury;
- Suffering from conditions with high exercise risk, such as hypertension or heart disease;
- Currently undergoing systematic psychological therapy;
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 |
|---|---|---|
| Aerobic exerciseModerate-intensity aerobic exercise for 30-50 minutes three times a week was added to usual medical therapy | Behavioural | Aerobic exercise group |
Primary outcome
Change from baseline in Hamilton Depression Rating Scale (HAMD)
Time frame: Week 4 and 8 of treatment duration
The outcome is assessed by HAMD-17 Scale.
15 secondary outcomes
Change from baseline in THINC-it score
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Week 4 and 8 of treatment duration
Response to treatment
Time frame: Week 4 and 8 of treatment duration
Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Ruminative Responses Scale (RRS)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Week 4 and 8 of treatment duration
Rating Scale for Side Effects (SERS) -Antidepressant
Time frame: Week 4 and 8 of treatment duration
Mood Disorder Questionnaire (MDQ)
Time frame: Week 4 and 8 of treatment duration
International Physical Activity Questionnaire (IPAQ)
Time frame: Week 4 and 8 of treatment duration
Biomarkers level
Time frame: Week 0 and 8 of treatment duration
Body weight in kilograms
Time frame: Week 4 and 8 of treatment duration
Body fat rate
Time frame: Week 4 and 8 of treatment duration
Brain imaging features
Time frame: Week 0 and 8 of treatment duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Depression - Major Depressive Disorder, run by Peking University 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 5 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihua Yue, Doctor (86-010-82805307, dryue@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hamilton Depression Rating Scale (HAMD) (time frame: Week 4 and 8 of treatment duration). 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 2 Jul 2025.