Depressive SymptomsNCT03300778
A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes
A study testing aerobic exercise in people with Depressive Symptoms and Hypomania Nos Single Episode or Unspecified, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial summary
This study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Hypomania Nos Single Episode or Unspecified
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2017to 12 Jan 2018
- Phase
- Interventional
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 or more DSM-IV defined depressive symptoms, with one as core symptoms ( lost interest or pleasure in activity or depressed mood), lasting for 1 week.
- 2 or more DSM-IV defined manic symptoms, last for 4 days, but falling short of the criteria for hypomania; or meeting DSM-5 defined symptoms criteria for hypomania, lasting 2-3 days.
- non-clinical subjects
Who cannot join
- DSM-IV defined major depressive disorder
- DSM-IV defined hypo/mania
- History of or current other Axis I Disorders
- Diagnosed neurological or musculoskeletal disorder/injury,
- Uncontrolled cardiovascular or metabolic diseases that are not suitable for running
- Diagnosed hypertension
Show all 10Show fewer
- Other diagnosed serious medical conditions that are not suitable for cycling
- Severe suicidal ideation
- Mental retardation
- Currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents
This study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children
Read the detailed description
Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in non-clinical and preclinical population and patients with mood disorders. This randomized controlled trial will investigate short-term (3 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical outcomes of high-risk states.
- Being tested
- aerobic exercise, Placebo controlled group
- Keywords
- neurocognition, high-risk, prognosis
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months
Placebo controlled groupBehavioural
6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Experimental | Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months Receives: Behavioral: aerobic exercise |
| Placebo controlled group | Placebo comparator | 6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment. Receives: Behavioral: Placebo controlled group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms
Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)
Measured: 12 weeks
Changes in neurocognitive function
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Measured: 12 weeks
Secondary outcomes (4)
changes in anxious symptoms
anxious symptoms measured by Symptom Checklist 90 (SCL-90)
Measured: 12 weeks
Changes in brain connectivity
using fMRI to measure brain connectivity
Measured: 12 weeks
Number of participants with subthreshold mood symptoms
number of participants who meet the subthreshold syndromes for depression and/or hypomania
Measured: 18 months
Changes in hypomanic symptoms
changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start10 Oct 2017
- Primary completion5 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
- Investigators
- kangguang Lin, MD; PhD, Principal investigator, Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)Guiyun Xu, MD, Study director, Guangzhou Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300778
- Sponsor's protocol ID
- Guangzhou Brain Hospital
- Status last verified
- Aug 2018
- First submitted
- 27 Sep 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents
- ClinicalTrials.gov ID
- NCT03300778
- Acronym / sponsor ID
- Guangzhou Brain Hospital
- Keywords
- neurocognition, high-risk, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 3 Oct 2017 (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.
This study will investigate the effects of aerobic exercise on mental states, cognition, and long-term outcomes in adolescents with subthreshold depressive and/or hypomanic syndromes and in non-clinical school children
Detailed description
Subthreshold depressive and hypomanic symptoms are common in adolescents, increasing the risk of developping into depression or bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in non-clinical and preclinical population and patients with mood disorders. This randomized controlled trial will investigate short-term (3 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (18 months) effects on the clinical outcomes of high-risk states.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Experimental | Behavioral: aerobic exerciseRunning at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months |
| Placebo controlled group | Placebo comparator | Behavioral: Placebo controlled group6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 2 or more DSM-IV defined depressive symptoms, with one as core symptoms ( lost interest or pleasure in activity or depressed mood), lasting for 1 week.
- 2 or more DSM-IV defined manic symptoms, last for 4 days, but falling short of the criteria for hypomania; or meeting DSM-5 defined symptoms criteria for hypomania, lasting 2-3 days.
- non-clinical subjects
Key exclusion criteria (10 listed)
- DSM-IV defined major depressive disorder
- DSM-IV defined hypo/mania
- History of or current other Axis I Disorders
- Diagnosed neurological or musculoskeletal disorder/injury,
- Uncontrolled cardiovascular or metabolic diseases that are not suitable for running
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 exerciseRunning at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months | Behavioural | aerobic exercise |
| Placebo controlled group6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment. | Behavioural | Placebo controlled group |
Primary outcome
Changes in depressive symptoms
Time frame: 12 weeks
Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)
Changes in neurocognitive function
Time frame: 12 weeks
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
4 secondary outcomes
changes in anxious symptoms
Time frame: 12 weeks
Changes in brain connectivity
Time frame: 12 weeks
Number of participants with subthreshold mood symptoms
Time frame: 18 months
Changes in hypomanic symptoms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
kangguang Lin, MD; PhD principal investigator
Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
Guiyun Xu, MD study director
Guangzhou Psychiatric Hospital
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 Depressive Symptoms and Hypomania Nos Single Episode or Unspecified, run by Guangzhou Psychiatric Hospital 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 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: finished, as of the sponsor's last update on 23 Aug 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depressive symptoms (time frame: 12 weeks). The study lists 2 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 23 Aug 2018.