A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents

Conditions
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Depressive Symptoms, Hypomania Nos Single Episode or Unspecified

Intervention / Treatment
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* Behavioral: aerobic exercise
* Behavioral: Placebo controlled group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic exercise<br>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 | Behavioral: aerobic exercise<br>* 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<br>|
| Placebo Comparator: Placebo controlled group<br>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. | Behavioral: Placebo controlled group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms | Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9) | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in anxious symptoms | anxious symptoms measured by Symptom Checklist 90 (SCL-90) | 12 weeks | 
| Changes in brain connectivity | using fMRI to measure brain connectivity | 12 weeks | 
| Number of participants with subthreshold mood symptoms | number of participants who meet the subthreshold syndromes for depression and/or hypomania | 18 months | 
| Changes in hypomanic symptoms | changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurocognition, high-risk, prognosis