Skip to main content
OpenTrials
Completed

NCT Number: NCT03300778

A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Hypomania Nos Single Episode or Unspecified

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510370, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

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

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.

Primary outcomes

  1. Changes in depressive symptoms

    Time frame: 12 weeks

    Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)

  2. Changes in neurocognitive function

    Time frame: 12 weeks

    Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise

Secondary outcomes

  1. changes in anxious symptoms

    Time frame: 12 weeks

    anxious symptoms measured by Symptom Checklist 90 (SCL-90)

  2. Changes in brain connectivity

    Time frame: 12 weeks

    using fMRI to measure brain connectivity

  3. Number of participants with subthreshold mood symptoms

    Time frame: 18 months

    number of participants who meet the subthreshold syndromes for depression and/or hypomania

  4. Changes in hypomanic symptoms

    Time frame: 12 weeks

    changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)

Sponsors and collaborators

Lead sponsor

Guangzhou Psychiatric Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.