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A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

G

Guangzhou Psychiatric Hospital

Status

Completed

Conditions

Depressive Symptoms
Hypomania Nos Single Episode or Unspecified

Treatments

Behavioral: aerobic exercise
Behavioral: Placebo controlled group

Study type

Interventional

Funder types

Other

Identifiers

NCT03300778
Guangzhou Brain Hospital

Details and patient eligibility

About

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

Full 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.

Enrollment

224 patients

Sex

All

Ages

12 to 14 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

224 participants in 2 patient groups, including a placebo group

aerobic exercise
Experimental group
Description:
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
Treatment:
Behavioral: aerobic exercise
Placebo controlled group
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: Placebo controlled group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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