A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300778
• Other study ID #: Guangzhou Brain Hospital
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: August 2018
• Source: Guangzhou Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 12, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Hypomania Nos Single Episode or Unspecified

Intervention

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 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.

Locations

Country	Name	City	State
China	Guangzhou Brain Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in depressive symptoms	Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)	12 weeks
Primary	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	changes in anxious symptoms	anxious symptoms measured by Symptom Checklist 90 (SCL-90)	12 weeks
Secondary	Changes in brain connectivity	using fMRI to measure brain connectivity	12 weeks
Secondary	Number of participants with subthreshold mood symptoms	number of participants who meet the subthreshold syndromes for depression and/or hypomania	18 months
Secondary	Changes in hypomanic symptoms	changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)	12 weeks