NCT04708691

Brief Summary

Major depressive depression (MDD) affects a quarter of young adults and is associated with marked global burden in this population. Recently, growing literature has shown that cognitive dysfunction is common in young adults with depression. There is a vast amount of evidence indicating aerobic exercise has positive effects on cognitive function in healthy as well as in subjects with depression. The results might be dependent on neuroplastic changes induced by aerobic exercise. Nevertheless, the neurocognitive mechanisms of aerobic exercise in young adults with depression has not received systematic investigation. In addition, the association between the underlying brain physiology and cognitive performance has not been explored so far. In this project, the investigators aim to explore the relevance of a single session of aerobic exercise for human brain physiology and the impact of respective physiological effects on cognitive processes in young adults with depression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2020

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 10, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

January 12, 2021

Last Update Submit

September 9, 2021

Conditions

Keywords

DepressionNeurophysiologyCognition

Outcome Measures

Primary Outcomes (1)

  • Cortical excitability

    TMS measurment

    4 weeks

Secondary Outcomes (1)

  • Cognitive task

    4 weeks

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

aerobic exercise for 30 mins

Other: Aerobic exercise

Control

NO INTERVENTION

sitting for 30 mins

Interventions

aerobic exercise

Aerobic exercise

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of major depressive disorder by a board-certified psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
  • Total score of the 17-item Hamilton Rating Scale for Depression (HAM-D) less than 7
  • Aged between 18 to 35 years
  • Right handedness

You may not qualify if:

  • A major depressive episode within the past three months
  • Pacemaker or deep brain stimulation
  • Metal implants in the head or neck area
  • Other major mental disorders including autism spectrum disorders, mental retardation, psychotic disorders, bipolar disorders, obsessive-compulsive disorder, and neurocognitive disorders
  • Alcohol or other illicit substance abuse
  • Neurological diseases involving the central nervous system
  • Major debilitating systemic diseases
  • Pregnancy
  • Breast feeding
  • Cigarette smoker
  • Color blindness
  • Take part in another study within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kuo Hsiao-I, PHD

    Assistant Professor, National Taiwan University

    PRINCIPAL INVESTIGATOR
  • Kuo Hsiao-I

    Assistant Professor, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuo Hsiao-I, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

May 1, 2020

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

September 10, 2021

Record last verified: 2021-05

Locations