NCT02023281

Brief Summary

The purpose of this study is to examine the effects of exercise on the symptoms of depression using serum levels of serotonin, catecholamine's, Alpha EEG asymmetry, and self-report of symptoms as markers. In an attempt to further understand the mechanisms of improved mood through exercise; this study will examine the known factors that contribute to depressed mood in a single study using serotonin and catecholamine levels via blood serum and EEG slow wave asymmetry. Such information can be useful in understanding the overall neurological components of depression and the effects of exercise on the brain in depressed individuals that would make the prescription of exercise a viable treatment option.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

2 months

First QC Date

December 23, 2013

Last Update Submit

December 23, 2013

Conditions

Keywords

DepressionExerciseNeurotransmittersCatecholiminesEEG

Outcome Measures

Primary Outcomes (1)

  • Scores on the Beck Depression Inventory-II

    The BDI-II is a 21 item self-report screening tool that measures symptoms of depression.

    Pre and post intervention over the 3 month span of the study

Secondary Outcomes (1)

  • Serum levels of serotonin and catecholomine

    Pre and post intervention over the 3 month span of the study

Other Outcomes (1)

  • Mean EEG alpha frequency data in the pre-frontal cortex.

    Pre and post intervention over the 3 month span of the study.

Study Arms (2)

Control Group

NO INTERVENTION

Control group will serve as a wait list and not be exposed to the intervention.

Experimental Group

EXPERIMENTAL

The experimental group will engage in a mild-moderate level of structured and clinically supervised exercise program for approx. 30-45 mins 2-3 days per week for 12 weeks

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

The experimental group will engage in mild-moderate level of exercise. This program will be structured and clinically supervised. Exercise will take place 2-3 days per week for a duration of 30-45 mins. for 12 weeks.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary diagnosis of depression
  • years of age
  • Physically fit to engage in physical exercise

You may not qualify if:

  • Participants with a history or current symptoms of psychosis
  • anticipation of psychiatric medication changes over the course of the study
  • Bipolar disorder or other disorder reflecting reality testing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liberty University

Lynchburg, Virginia, 24502, United States

Location

Centra Health; Health Works

Lynchburg, Virginia, 24503, United States

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Timothy H Barclay, Ph.D.

    Liberty University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor; Licensed Clinical Psychologist

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations