- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023281
The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers
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.
Study Overview
Detailed Description
There is an increasing demand for clinical effective, safe, and cost conscious forms of treatment for depression. Research shows depression to account for the largest decrease in overall health compared to asthma, angina, arthritis, and diabetes (Maussavi, 2007). The cost of lost productivity at work due to depression is a new focus of research as no current and accurate numbers exist. Stewart, Ricci, Hahn, & Morganstein (2013) were among the first to examine this issue and found that lost productivity due to depression cost an estimated $44 billion dollars per year in spite of current medical treatments commonly prescribed. The lost productivity among those with depression and the low level of treatment suggest that there may be cost effective opportunities for improving depression outcomes within the general workforce and society at large.
The question of value regarding the use of exercise as a treatment for depression has remained a source of investigation in recent years. In cooperation with Centra Health and Liberty University, this study seeks to understand the mechanisms that make exercise a viable treatment in depression by examining self-report of symptoms, serum levels of serotonin and catecholamines (epinephrine, norepinephrin, and dopamine) and frontal slow wave EEG activity as markers. Although these markers have been examined individually in previous studies, this is the only known study that examines each of these components in a single study. 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 in depression.
Multiple trials, meta-analyses, and reviews have been conducted in the attempt to clarify the use of exercise in depressed patients. Research has shown that exercise as a treatment may result in fewer relapses than sertraline (Strohle, 2009). Similar results are indicated when exercise is prescribed as an adjunct treatment with psychotherapy (Balon, Sidhu, & Pankhuree, 2009; Blumenthal, Smith, & Hoffman, 2012; Gill, Womack, & Safranek, 2010). Preliminary characteristics of the ideal dosage of exercise as a treatment have been researched, although a definitive dose-response curve has yet to be produced (Callaghan, Khalil, Morres, & Carter, 2011; Perraton, Kumar, & Machotka, 2010).
Electroencephalographic (EEG) scans have been shown to demonstrate a left frontal bias in alpha (8-12 Hz) and theta (4-7 Hz) wave activity (Allen, Urry, Hitt, & Coan, 2004; Demos, 2005; Iosifescu et al., 2008; Nissen et al., 2006). The up-training or down-training of individual bandwidths in the treatment of depression, anxiety, ADHD, and traumatic brain injury have long been established (La Vaque, 2002). Although there are no established norms for neurotransmitter levels, we know through clinical medication trials that the inhibition of the reuptake of serotonin and or norepinephrine improve mood. Previous studies examining low levels of serotonin and decreased mood have found a correlation between exercise and increased serotonin availability without the use of pharmaceuticals (Chaouloff et al., 1985; Ernst, Olsen, Pinel, Lam, & Christie, 2006; Jacobs & Fornal, 1999). More routine type studies often use neurotransmitter levels as markers (Lande, Williams, Fileta, 2012; Lidberg, Tuck, Asberg, Scalia-Tomba, & Bertilsson, 1985; Mann & Stanley, 1984).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Lynchburg, Virginia, United States, 24502
- Liberty University
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Lynchburg, Virginia, United States, 24503
- Centra Health; Health Works
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary diagnosis of depression
- 18-65 years of age
- Physically fit to engage in physical exercise
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control Group
Control group will serve as a wait list and not be exposed to the intervention.
|
|
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EXPERIMENTAL: Experimental Group
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
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scores on the Beck Depression Inventory-II
Time Frame: Pre and post intervention over the 3 month span of the study
|
The BDI-II is a 21 item self-report screening tool that measures symptoms of depression.
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Pre and post intervention over the 3 month span of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum levels of serotonin and catecholomine
Time Frame: Pre and post intervention over the 3 month span of the study
|
Blood collection pre and post intervention for the processing of serum for serotonin and catecholomine.
|
Pre and post intervention over the 3 month span of the study
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean EEG alpha frequency data in the pre-frontal cortex.
Time Frame: Pre and post intervention over the 3 month span of the study.
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Participants will have an EEG measuring pre-frontal cortex mean alpha frequency.
|
Pre and post intervention over the 3 month span of the study.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy H Barclay, Ph.D., Liberty University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LU4261 from WyndhurstCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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