CClinicalTrials.gg
CompletedNCT03300778Updated Aug 23, 2018

A Study of Aerobic Exercise for Adolescents With Subthreshold Mood Syndromes

An interventional study of aerobic exercise and Placebo controlled group in Depressive Symptoms and Hypomania Nos Single Episode or Unspecified, sponsored by Guangzhou Psychiatric Hospital. Completed at 1 site in China. Open to participants aged 12 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-23.

Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
12 Years to 14 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Depressive Symptoms
  • Hypomania Nos Single Episode or Unspecified

Browse trials for

Keywords

  • neurocognition
  • high-risk
  • prognosis
03

Who can participate

Ages eligible
12 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
224 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralaerobic 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

  • BehavioralPlacebo 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.

05

What researchers measure

Primary outcomes

  1. Changes in depressive symptoms

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

    Time frame: 12 weeks

  2. Changes in neurocognitive function

    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 outcomes

  1. changes in anxious symptoms

    anxious symptoms measured by Symptom Checklist 90 (SCL-90)

    Time frame: 12 weeks

  2. Changes in brain connectivity

    using fMRI to measure brain connectivity

    Time frame: 12 weeks

  3. Number of participants with subthreshold mood symptoms

    number of participants who meet the subthreshold syndromes for depression and/or hypomania

    Time frame: 18 months

  4. Changes in hypomanic symptoms

    changes in hypomanic symptoms measured by Hypomania Check List-15(HCL-15)

    Time frame: 12 weeks

06

Study locations

1 site
  • Guangzhou Brain Hospital
    Guangzhou, Guangdong 510370, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03300778
Lead sponsor
Guangzhou Psychiatric Hospital
Responsible party
Kangguang Lin (MD, PhD, Guangzhou Psychiatric Hospital) — Principal investigator
First posted
Oct 3, 2017
Start date
Oct 10, 2017
Primary completion
Jan 5, 2018
Completion
Jan 12, 2018
Last update
Aug 23, 2018

Study contacts

kangguang Lin, MD; PhD
principal investigator · Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
Guiyun Xu, MD
study director · Guangzhou Psychiatric Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion