Impact of an Eight Week Exercise Intervention in Treating Major Depressive Disorder

NCT03191994 | Unknown

• 1 other identifier: UOntarioIT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the impact of a structured eight week exercise intervention as an add-on therapy in treating Major Depressive Disorder. Using behavioural techniques and neuroimaging to measure changes in brain function following an exercise intervention in people with clinical depression. By correlating changes in the hippocampus with changes in HPA axis hormones, inflammatory cytokines and growth factors it is possible to determine which of the biochemical markers is most predictive of improved neural function.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Brain function during an associative memory task

  Participants will be MRI safety screened to ensure no metal implants. Using fMRI to determine brain activity during an associative memory task. Participants will be scanned on a 3-Tesla MR scanner. Scans will be acquired in the oblique coronal plane of the hippocampus. 416 functional scans will be acquired with a T2\*-weighted gradient EPI sequence. Preprocessing will be performed using Statistical Parametric Mapping. General linear model will be performed at the single-subject level and statistical contrasts will be created modeling the hemodynamic response function of correct and incorrect responses. Random effects analysis will be performed using the contrast of t-test of correct \> incorrect. Significant clusters from an independent samples t-test for correct\>incorrect at baseline will be used to extract contrast beta values for correct\>incorrect in pre and post scans. Average beta values will be imported into SPSS and a 2 x 2 repeated measures ANOVA (group x time).

  eight weeks

Secondary Outcomes (5)

• Depression scores

  eight weeks

• Biochemical markers

  eight weeks

• Sleep quality

  eight weeks

• Anxiety

  eight weeks

• Memory performance

  eight weeks

Study Arms (4)

MDD exercise group

EXPERIMENTAL

This group will receive eight weeks of moderate exercise in addition to their usual treatment

Behavioral: Exercise

MDD control group

NO INTERVENTION

This group will receive usual care with no exercise

Healthy Exercise

EXPERIMENTAL

This group will perform an eight week moderate intensity exercise intervention

Behavioral: Exercise

Healthy control

NO INTERVENTION

This group will not perform exercise

Interventions

Exercise BEHAVIORAL

a structured, supervised eight week moderate intensity exercise intervention

Healthy Exercise; MDD exercise group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• all participants must have no contraindications to exercise, be considered 'low active' (exercise less than 3 times per week for less than 20 minutes), MRI safe MDD group must be diagnosed by psychiatrist based on DSM-V criteria and pharmacological medication stabilized for a minimum of 6 weeks

You may not qualify if:

• no immune disorders

Sponsors & Collaborators

• University of Ontario Institute of Technology: lead

Study Sites (1)

University of Ontario Institute of Technology

Oshawa, Ontario, L1H 7K4, Canada

RECRUITING

Related Publications (9)

• Airaksinen E, Larsson M, Lundberg I, Forsell Y. Cognitive functions in depressive disorders: evidence from a population-based study. Psychol Med. 2004 Jan;34(1):83-91. doi: 10.1017/s0033291703008559.

  PMID: 14971629 BACKGROUND

• Blumenthal JA, Babyak MA, Doraiswamy PM, Watkins L, Hoffman BM, Barbour KA, Herman S, Craighead WE, Brosse AL, Waugh R, Hinderliter A, Sherwood A. Exercise and pharmacotherapy in the treatment of major depressive disorder. Psychosom Med. 2007 Sep-Oct;69(7):587-96. doi: 10.1097/PSY.0b013e318148c19a. Epub 2007 Sep 10.

  PMID: 17846259 BACKGROUND

• Blumenthal JA, Babyak MA, Moore KA, Craighead WE, Herman S, Khatri P, Waugh R, Napolitano MA, Forman LM, Appelbaum M, Doraiswamy PM, Krishnan KR. Effects of exercise training on older patients with major depression. Arch Intern Med. 1999 Oct 25;159(19):2349-56. doi: 10.1001/archinte.159.19.2349.

  PMID: 10547175 BACKGROUND

• Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.

  PMID: 17765329 BACKGROUND

• Davenport MH, Hogan DB, Eskes GA, Longman RS, Poulin MJ. Cerebrovascular reserve: the link between fitness and cognitive function? Exerc Sport Sci Rev. 2012 Jul;40(3):153-8. doi: 10.1097/JES.0b013e3182553430.

  PMID: 22504726 BACKGROUND

• Erickson KI, Miller DL, Roecklein KA. The aging hippocampus: interactions between exercise, depression, and BDNF. Neuroscientist. 2012 Feb;18(1):82-97. doi: 10.1177/1073858410397054. Epub 2011 Apr 29.

  PMID: 21531985 BACKGROUND

• Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.

  PMID: 21282661 BACKGROUND

• Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.

  PMID: 20124113 BACKGROUND

• Gourgouvelis J, Yielder P, Murphy B. Exercise Promotes Neuroplasticity in Both Healthy and Depressed Brains: An fMRI Pilot Study. Neural Plast. 2017;2017:8305287. doi: 10.1155/2017/8305287. Epub 2017 Jul 30.

  PMID: 28828187 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bernadette Murphy, PhD

  University of Ontario Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette Murphy, PhD

CONTACT

905.721.8668; bernadette.murphy@uoit.ca

Joanne Gourgouvelis, MHSc

CONTACT

905-550-4055; joanne.gourgouvelis@uoit.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: MDD exercise group, MDD control group, Healthy exercise group, Healthy control group

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 19, 2017
• Study Start: January 2, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)