NCT03300778

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

September 27, 2017

Last Update Submit

August 22, 2018

Conditions

Depressive SymptomsHypomania Nos Single Episode or Unspecified

Keywords

neurocognitionhigh-riskprognosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • changes in anxious symptoms

    12 weeks

  • Changes in brain connectivity

    12 weeks

  • Number of participants with subthreshold mood symptoms

    18 months

  • Changes in hypomanic symptoms

    12 weeks

Study Arms (2)

aerobic exercise

EXPERIMENTAL

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

Placebo controlled group

PLACEBO COMPARATOR

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

Interventions

aerobic exerciseBEHAVIORAL

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

aerobic exercise
Placebo controlled groupBEHAVIORAL

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.

Placebo controlled group

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510370, China

Location

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • kangguang Lin, MD; PhD

    Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

    PRINCIPAL INVESTIGATOR

  • Guiyun Xu, MD

    Guangzhou Psychiatric Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 3, 2017

Study Start

October 10, 2017

Primary Completion

January 5, 2018

Study Completion

January 12, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

CN(1)