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Clinical Trials/NCT03300778
NCT03300778
Completed
Not Applicable

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

Guangzhou Psychiatric Hospital1 site in 1 country224 target enrollmentOctober 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Guangzhou Psychiatric Hospital
Enrollment
224
Locations
1
Primary Endpoint
Changes in neurocognitive function
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2017
End Date
January 12, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Psychiatric Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kangguang Lin

MD, PhD

Guangzhou Psychiatric Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Changes in depressive symptoms

Time Frame: 12 weeks

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

Secondary Outcomes

  • Changes in hypomanic symptoms(12 weeks)
  • Changes in brain connectivity(12 weeks)
  • changes in anxious symptoms(12 weeks)
  • Number of participants with subthreshold mood symptoms(18 months)

Study Sites (1)

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