A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

Not Applicable

Completed

• Conditions: Depressive Symptoms; Hypomania Nos Single Episode or Unspecified
• Interventions: Behavioral: Placebo controlled group; Behavioral: aerobic exercise

• Registration Number: NCT03300778
• Lead Sponsor: Guangzhou Psychiatric Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-03
• Study Start: 2017-10-10
• Primary Completion: 2018-01-05
• Study Completion: 2018-01-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo controlled group	Placebo controlled group	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.
aerobic exercise	aerobic exercise	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

Primary Outcome Measures

Name	Time	Method
Changes in neurocognitive function	12 weeks	Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Changes in depressive symptoms	12 weeks	Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangzhou Brain Hospital; 🇨🇳 Guangzhou, Guangdong, China