A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

NCT ID: NCT03300778

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2018-01-12

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.

Conditions

Depressive Symptoms; Hypomania Nos Single Episode or Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: BEHAVIORAL

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 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.

Group Type: PLACEBO_COMPARATOR

Placebo controlled group

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kangguang Lin

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kangguang Lin, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

Guiyun Xu, MD

Role: STUDY_DIRECTOR

Guangzhou Psychiatric Hospital

Locations

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Guangzhou Brain Hospital

Identifier Type: -

Identifier Source: org_study_id