Clinical trial NCT03300778: A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes
Official title: A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Hypomania Nos Single Episode or Unspecified
Keywords: neurocognition
high-risk
prognosis
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2017-10-03
Enrollment: 224
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. 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. 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.
3. 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

Primary outcomes:
measure: Changes in depressive symptoms
timeFrame: 12 weeks
measure: Changes in neurocognitive function
timeFrame: 12 weeks
Secondary outcomes:
measure: changes in anxious symptoms
timeFrame: 12 weeks
measure: Changes in brain connectivity
timeFrame: 12 weeks
measure: Number of participants with subthreshold mood symptoms
timeFrame: 18 months
measure: Changes in hypomanic symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
name: kangguang Lin, MD; PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Psychiatric Hospital
name: Guiyun Xu, MD
role: STUDY_DIRECTOR
References: