A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

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

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

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Hypomania Nos Single Episode or Unspecified
• Intervention / Treatment: Behavioral: aerobic exercise; Behavioral: Placebo controlled group

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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510370
      • Guangzhou Brain Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangzhou Psychiatric Hospital
• Investigators: Study Director: Guiyun Xu, MD, Guangzhou Psychiatric Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: prognosis; high-risk; neurocognition
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Depression; Mania
• Other Study ID Numbers: Guangzhou Brain Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No