The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers

Depression Clinical Trial

Official title:

The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787201
• Other study ID #: LU4261
• Secondary ID: Centra Health
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: November 21, 2013
• Start date: March 2013
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: Liberty University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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, norepinephrine, 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Exercise
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 6 weeks.

Locations

Country	Name	City	State
United States	Centra Health; Health Works	Lynchburg	Virginia
United States	Liberty University	Lynchburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Liberty University	Centura Health

Country where clinical trial is conducted

United States, 

References & Publications (10)

Allen JJ, Urry HL, Hitt SK, Coan JA. The stability of resting frontal electroencephalographic asymmetry in depression. Psychophysiology. 2004 Mar;41(2):269-80. — View Citation

Callaghan P, Khalil E, Morres I, Carter T. Pragmatic randomised controlled trial of preferred intensity exercise in women living with depression. BMC Public Health. 2011 Jun 12;11:465. doi: 10.1186/1471-2458-11-465. — View Citation

Chaouloff F, Elghozi JL, Guezennec Y, Laude D. Effects of conditioned running on plasma, liver and brain tryptophan and on brain 5-hydroxytryptamine metabolism of the rat. Br J Pharmacol. 1985 Sep;86(1):33-41. — View Citation

Ernst C, Olson AK, Pinel JP, Lam RW, Christie BR. Antidepressant effects of exercise: evidence for an adult-neurogenesis hypothesis? J Psychiatry Neurosci. 2006 Mar;31(2):84-92. Review. — View Citation

Gill A, Womack R, Safranek S. Clinical Inquiries: Does exercise alleviate symptoms of depression? J Fam Pract. 2010 Sep;59(9):530-1. Review. — View Citation

Iosifescu DV, Greenwald S, Devlin P, Perlis RH, Denninger JW, Alpert JE, Fava M. Pretreatment frontal EEG and changes in suicidal ideation during SSRI treatment in major depressive disorder. Acta Psychiatr Scand. 2008 Apr;117(4):271-6. doi: 10.1111/j.1600-0447.2008.01156.x. Epub 2008 Feb 26. — View Citation

Lande, G. R., Banks-Williams, L., & Fileta, B. (2012). The forensic assessment of combat-related irritability with whole blood serotonin levels: a pilot study. The Journal of Forensic Psychiatry & Psychology, 23(5-6). 654-663.

Perraton LG, Kumar S, Machotka Z. Exercise parameters in the treatment of clinical depression: a systematic review of randomized controlled trials. J Eval Clin Pract. 2010 Jun;16(3):597-604. doi: 10.1111/j.1365-2753.2009.01188.x. Epub 2009 Dec 18. Review. — View Citation

Stewart WF, Ricci JA, Chee E, Hahn SR, Morganstein D. Cost of lost productive work time among US workers with depression. JAMA. 2003 Jun 18;289(23):3135-44. Erratum in: JAMA. 2003 Oct 22;290(16):2218. — View Citation

Ströhle A. Physical activity, exercise, depression and anxiety disorders. J Neural Transm (Vienna). 2009 Jun;116(6):777-84. doi: 10.1007/s00702-008-0092-x. Epub 2008 Aug 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean EEG alpha frequency data in the pre-frontal cortex.	Participants will have an EEG measuring pre-frontal cortex mean alpha frequency.	Change from baseline in alpha mean frequency at 6 weeks	No
Primary	Scores on the Beck Depression Inventory-II	The BDI-II is a 21 item self-report screening tool that measures symptoms of depression.	Change from baseline in BDI-II scores at 6 weeks	No
Secondary	Serum levels of serotonin and catecholamines	Blood collection pre and post intervention for the processing of serum for serotonin and catecholamines.	Change from baseline in serotonin and catecholimine levels at 6 weeks	No