Major Depressive DisorderNCT03191994
Impact of an Eight Week Exercise Intervention in Treating Major Depressive Disorder
A study testing Exercise in people with Major Depressive Disorder, run by University of Ontario Institute of Technology at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- no immune disorders
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Ontario Institute of Technology
Oshawa, Ontario, L1H 7K4
Bernadette Murphy, PhD
Joanne Gourgouvelis, PhD, 905-550-4055, joanne.gourgouvelis@uoit.ca
About this study
Official title: Exercise Promotes Neuroplasticity in Depressed and Healthy Brains: An fMRI Pilot Study
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.
Read the detailed description
Memory impairment is the most frequently reported cognitive symptom in people with depression. However, research in this area has presented mixed findings in terms of the type, severity and specificity of memory deficits. One finding that has been well established is the impairment in episodic memory (memory for a specific past experience in one's life) with a sparing of semantic memory (present knowledge of universal truths such as "the sky is blue"), and short-term memory. Behavioural and neuroimaging studies investigating the stage of the memory deficit in people with depression have found that both the encoding and retrieval processes are impaired. Although the neural underpinnings of impaired memory in MDD are not completely understood, the majority of evidence implicates abnormal activity in the hippocampal region critical for normal memory formation.
Exercise for depression has been a common research theme for the past several years however its mechanism of action remains unknown. Many studies have reported higher levels of cardiorespiratory fitness and increased habitual physical activity being associated with lower depressive symptomatology and greater emotional well-being, while lower levels of cardiorespiratory fitness being associated with increased risk of developing depressive illness. Exercise alone or in combination with other treatment options, such as pharmacotherapy or cognitive behavioural therapy have all been effective in treating depression with response rates for exercise being comparable to these mainstream therapies. Exercise protects against the development of neurodegenerative diseases delays the negative effects of aging and improves sleep quality. Exercise also reduces inflammation, normalizes cortisol secretion, increases hippocampal neurogenesis, increases cerebrovascular perfusion, improves the structure and function of the hippocampus, facilitates neurocognitive recovery from traumatic brain injury reverses brain volume loss in elderly and schizophrenic individuals and improves learning and memory. These findings suggest that the relationship between fitness and cognition is partly mediated by processes that involve cerebral circulation. These positive effects of exercise on neuroanatomy and vascularization can be partly explained by the interactive cascade of growth factor signalling associated with exercise that increases the ability of cerebral blood vessels to respond to demand. Habitual exercise is an effective way to improve endothelial function by increasing arterial compliance and decreasing arterial stiffness, oxidative stress, and vascular inflammation.
The overall goal of this research study is to investigate the effects of a well-defined, structured, supervised exercise program on brain function in healthy and clinically depressed individuals. This research aims to fill the gaps in the literature by elucidating the anti-depressant mechanisms which exercise targets and if these effects parallel young healthy sedentary individuals.
To investigate the effects of a moderate-intensity structured, supervised 8 week exercise program in people with MDD when combined with a Mental Health Day Treatment (MHDT) program, as compared to the MHDT on its own. All outcome measures will be assessed at baseline and 8 weeks. A non-depressed exercise control group will be used to compare the effects of exercise in depressed and non-depressed individuals:
- depressive symptoms ii. anxiety iii. sleep quality iv. plasma IL-1β, IL-1ra, IL-6, IFN-γ, TNF-α and IL-10, BDNF v. salivary cortisol vi. performance on an associative memory task and concomitant fMRI hippocampal activation.
- Conditions
- Major Depressive Disorder
- Being tested
- Exercise
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
a structured, supervised eight week moderate intensity exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| MDD exercise group | Experimental | This group will receive eight weeks of moderate exercise in addition to their usual treatment Receives: 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 Receives: Behavioral: Exercise |
| Healthy control | No intervention | This group will not perform exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: eight weeks
Secondary outcomes (5)
Depression scores
Depression severity was determined using the self-reported Beck Depression Inventory (BDI). The BDI measures depression severity ranging from mile to severe depression. The higher the score the greater the depression severity.
Measured: eight weeks
Biochemical markers
Peripheral venous blood will be collected from each participant at baseline and eight weeks by venipuncture into ethylenediaminetetraacetic acid (EDTA) tubes. Plasma proteins IL-1β, IL-1Ra, IL-6, IL-10 TNF-α, BDNF and total CTHB will be quantified using enzyme-linked immunosorbant assays (ELISA) following manufacturer's protocols (R\&D Systems, MN, USA; BioLegend, CA, USA). Cortisol was measured using participant saliva and quantified using ELISA. Outcome measures will be measured in picograms/ml
Measured: eight weeks
Sleep quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index a (PSQI) a self reported questionnaire. Sleep quality over the score over 5 is indicative of poor sleep quality.
Measured: eight weeks
Anxiety
Anxiety will be measured using the Hospital Anxiety Depression Scale (HADS) a self-reported questionnaire. The higher the score the greater the anxiety severity.
Measured: eight weeks
Memory performance
Associated memory task using face and names pairs. This was performed during the fMRI. Outcome measures include correct and incorrect reponses
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start2 Jan 2014
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- MDD exercise group, MDD control group, Healthy exercise group, Healthy control group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ontario Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernadette Murphy, University of Ontario Institute of Technology
- Investigators
- Bernadette Murphy, PhD, Principal investigator, University of Ontario Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191994
- Sponsor's protocol ID
- UOntarioIT
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14971629Blumenthal 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.
PubMed 17846259Blumenthal 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.
PubMed 10547175Cotman 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.
PubMed 17765329Davenport 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.
PubMed 22504726Erickson 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.
PubMed 21531985Erickson 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.
PubMed 21282661Pajonk 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.
PubMed 20124113Gourgouvelis 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.
PubMed 28828187
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Promotes Neuroplasticity in Depressed and Healthy Brains: An fMRI Pilot Study
- ClinicalTrials.gov ID
- NCT03191994
- Acronym / sponsor ID
- UOntarioIT
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Ontario Institute of TechnologyUniversity, hospital or other
- Study start
- 2 Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Memory impairment is the most frequently reported cognitive symptom in people with depression. However, research in this area has presented mixed findings in terms of the type, severity and specificity of memory deficits. One finding that has been well established is the impairment in episodic memory (memory for a specific past experience in one's life) with a sparing of semantic memory (present knowledge of universal truths such as "the sky is blue"), and short-term memory. Behavioural and neuroimaging studies investigating the stage of the memory deficit in people with depression have found that both the encoding and retrieval processes are impaired. Although the neural underpinnings of impaired memory in MDD are not completely understood, the majority of evidence implicates abnormal activity in the hippocampal region critical for normal memory formation.
Exercise for depression has been a common research theme for the past several years however its mechanism of action remains unknown. Many studies have reported higher levels of cardiorespiratory fitness and increased habitual physical activity being associated with lower depressive symptomatology and greater emotional well-being, while lower levels of cardiorespiratory fitness being associated with increased risk of developing depressive illness. Exercise alone or in combination with other treatment options, such as pharmacotherapy or cognitive behavioural therapy have all been effective in treating depression with response rates for exercise being comparable to these mainstream therapies. Exercise protects against the development of neurodegenerative diseases delays the negative effects of aging and improves sleep quality. Exercise also reduces inflammation, normalizes cortisol secretion, increases hippocampal neurogenesis, increases cerebrovascular perfusion, improves the structure and function of the hippocampus, facilitates neurocognitive recovery from traumatic brain injury reverses brain volume loss in elderly and schizophrenic individuals and improves learning and memory. These findings suggest that the relationship between fitness and cognition is partly mediated by processes that involve cerebral circulation. These positive effects of exercise on neuroanatomy and vascularization can be partly explained by the interactive cascade of growth factor signalling associated with exercise that increases the ability of cerebral blood vessels to respond to demand. Habitual exercise is an effective way to improve endothelial function by increasing arterial compliance and decreasing arterial stiffness, oxidative stress, and vascular inflammation.
The overall goal of this research study is to investigate the effects of a well-defined, structured, supervised exercise program on brain function in healthy and clinically depressed individuals. This research aims to fill the gaps in the literature by elucidating the anti-depressant mechanisms which exercise targets and if these effects parallel young healthy sedentary individuals.
To investigate the effects of a moderate-intensity structured, supervised 8 week exercise program in people with MDD when combined with a Mental Health Day Treatment (MHDT) program, as compared to the MHDT on its own. All outcome measures will be assessed at baseline and 8 weeks. A non-depressed exercise control group will be used to compare the effects of exercise in depressed and non-depressed individuals:
- depressive symptoms ii. anxiety iii. sleep quality iv. plasma IL-1β, IL-1ra, IL-6, IFN-γ, TNF-α and IL-10, BDNF v. salivary cortisol vi. performance on an associative memory task and concomitant fMRI hippocampal activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- MDD exercise group, MDD control group, Healthy exercise group, Healthy control group
| Arm | Type | Receives |
|---|---|---|
| MDD exercise group | Experimental | Behavioral: ExerciseThis group will receive eight weeks of moderate exercise in addition to their usual treatment |
| MDD control group | No intervention | –This group will receive usual care with no exercise |
| Healthy Exercise | Experimental | Behavioral: ExerciseThis group will perform an eight week moderate intensity exercise intervention |
| Healthy control | No intervention | –This group will not perform exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- no immune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisea structured, supervised eight week moderate intensity exercise intervention | Behavioural | Healthy Exercise, MDD exercise group |
Primary outcome
Brain function during an associative memory task
Time frame: eight weeks
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).
5 secondary outcomes
Depression scores
Time frame: eight weeks
Biochemical markers
Time frame: eight weeks
Sleep quality
Time frame: eight weeks
Anxiety
Time frame: eight weeks
Memory performance
Time frame: eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Background: PubMed 14971629Airaksinen 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.
- Background: PubMed 17846259Blumenthal 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.
- Background: PubMed 10547175Blumenthal 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.
- Background: PubMed 17765329Cotman 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.
- Background: PubMed 22504726Davenport 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.
- Background: PubMed 21531985Erickson 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.
- Background: PubMed 21282661Erickson 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.
- Background: PubMed 20124113Pajonk 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.
- Derived from this study: PubMed 28828187Gourgouvelis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadette Murphy, PhD principal investigator
University of Ontario Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Major Depressive Disorder, run by University of Ontario Institute of Technology at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernadette Murphy, PhD (905.721.8668 ext. 2778, bernadette.murphy@uoit.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain function during an associative memory task (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191994, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.