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A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

Primary Purpose

Depressive Symptoms, Hypomania Nos Single Episode or Unspecified

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aerobic exercise
Placebo controlled group
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring neurocognition, high-risk, prognosis

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts 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

Sites / Locations

  • Guangzhou Brain Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aerobic exercise

Placebo controlled group

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2017
Last Updated
August 22, 2018
Sponsor
Guangzhou Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03300778
Brief Title
A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes
Official Title
A Randomised Controlled Trial of Aerobic Exercise for Adolescents With Subthreshold Depressive and/or Hypomanic Syndrome and for Non-clinical Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Hypomania Nos Single Episode or Unspecified
Keywords
neurocognition, high-risk, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Experimental
Arm 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
Arm Title
Placebo controlled group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Placebo controlled group
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in depressive symptoms
Description
Changes in depressive symptoms measured by Patient Health Questionnaire (PHQ-9)
Time Frame
12 weeks
Title
Changes in neurocognitive function
Description
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
changes in anxious symptoms
Description
anxious symptoms measured by Symptom Checklist 90 (SCL-90)
Time Frame
12 weeks
Title
Changes in brain connectivity
Description
using fMRI to measure brain connectivity
Time Frame
12 weeks
Title
Number of participants with subthreshold mood symptoms
Description
number of participants who meet the subthreshold syndromes for depression and/or hypomania
Time Frame
18 months
Title
Changes in hypomanic symptoms
Description
changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kangguang Lin, MD; PhD
Organizational Affiliation
Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guiyun Xu, MD
Organizational Affiliation
Guangzhou Psychiatric Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Guangzhou Brain Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

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