Major Depressive DisorderPEXATNCT02612142
Physical EXercise as an Adjunct Treatment for Depression
A study testing physical exercise in people with Major Depressive Disorder, run by Université de Reims Champagne-Ardenne.
Trial summary
35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of major depressive disorder (MDD)
- antidepressant drug therapy initiated for less than 2 weeks
- score of 29 or more on the Beck depression inventory
Who cannot join
- medical contraindication for exercise practice
- inability to understand written French
- beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy)
About this study
Official title: Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy.
35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day. Depressive symptoms were assessed the day before the beginning of intervention and the day after the end of intervention for participants of both groups.
Read the detailed description
In the aerobic exercise (AE) group, the intervention consisted of 30 minutes of daily brisk walking or jogging. This was done individually and supervised. Participants who missed > 2 training sessions were considered as non-completers. Exercise intensity had to be maintained within 65%-75% of age-predicted maximal heart rate, as commonly prescribed in studies using aerobic exercise to alleviate depression. Heart rate monitoring devices were used.
Participants in the stretching (ST) group also performed a daily 30 minutes exercise program but this was "sham" exercise, consisting of stretching exercises. Several muscle groups (thighs, calves, gluteal, shoulders, back) were stretched for 60 seconds, with equivalent resting intervals between stretching series. These activities were also individual and supervised. As was the case for the AE intervention, participants who missed > 2 training sessions were considered as non-completers.
Participants in the control (NI) group received no intervention other than prescribed medication.
All participants started antidepressants within less than 2 weeks before study entry.
- Conditions
- Major Depressive Disorder
- Being tested
- physical 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.
physical exerciseBehavioural
endurance-training or stretching (sham exercise)
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise (AE) | Experimental | Intervention type: Behavioral. Intervention name: Aerobic exercise Intervention description: 10 days of daily aerobic exercise (brisk walking, jogging); duration: 30 minutes per session; intensity: 65%-75% of age-predicted maximal heart rate. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day). Receives: Behavioral: physical exercise |
| stretching exercise (ST) | Sham comparator | Intervention type: Behavioral. Intervention name: Stretching exercise Intervention description: 10 days of daily stretching exercise; duration: 30 minutes per session. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day). Receives: Behavioral: physical exercise |
| no intervention (NI) | No intervention | No behavioral intervention. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity).
Measured: Baseline and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startJun 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabien Legrand, Université de Reims Champagne-Ardenne
- Investigators
- Zodi Imad, MD, Principal investigator, Etablissement Public de Santé Mentale de la Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612142
- Sponsor's protocol ID
- EPSMM-2011
- Acronym
- PEXAT
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy.
- ClinicalTrials.gov ID
- NCT02612142
- Acronym / sponsor ID
- PEXAT / EPSMM-2011
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Nov 2015 (estimated)
- 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.
35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day. Depressive symptoms were assessed the day before the beginning of intervention and the day after the end of intervention for participants of both groups.
Detailed description
In the aerobic exercise (AE) group, the intervention consisted of 30 minutes of daily brisk walking or jogging. This was done individually and supervised. Participants who missed > 2 training sessions were considered as non-completers. Exercise intensity had to be maintained within 65%-75% of age-predicted maximal heart rate, as commonly prescribed in studies using aerobic exercise to alleviate depression. Heart rate monitoring devices were used.
Participants in the stretching (ST) group also performed a daily 30 minutes exercise program but this was "sham" exercise, consisting of stretching exercises. Several muscle groups (thighs, calves, gluteal, shoulders, back) were stretched for 60 seconds, with equivalent resting intervals between stretching series. These activities were also individual and supervised. As was the case for the AE intervention, participants who missed > 2 training sessions were considered as non-completers.
Participants in the control (NI) group received no intervention other than prescribed medication.
All participants started antidepressants within less than 2 weeks before study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise (AE) | Experimental | Behavioral: physical exerciseIntervention type: Behavioral. Intervention name: Aerobic exercise Intervention description: 10 days of daily aerobic exercise (brisk walking, jogging); duration: 30 minutes per session; intensity: 65%-75% of age-predicted maximal heart rate. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day). |
| stretching exercise (ST) | Sham comparator | Behavioral: physical exerciseIntervention type: Behavioral. Intervention name: Stretching exercise Intervention description: 10 days of daily stretching exercise; duration: 30 minutes per session. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day). |
| no intervention (NI) | No intervention | –No behavioral intervention. All participants were treated with either paroxetine (20-50mg/day), fluoxetine (20-80mg/day) or bupropion (100-200mg/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of major depressive disorder (MDD)
- antidepressant drug therapy initiated for less than 2 weeks
- score of 29 or more on the Beck depression inventory
Key exclusion criteria (3 listed)
- medical contraindication for exercise practice
- inability to understand written French
- beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy)
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 |
|---|---|---|
| physical exerciseendurance-training or stretching (sham exercise) | Behavioural | aerobic exercise (AE), stretching exercise (ST) |
Primary outcome
Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity).
Time frame: Baseline and 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Zodi Imad, MD principal investigator
Etablissement Public de Santé Mentale de la Marne
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Major Depressive Disorder, run by Université de Reims Champagne-Ardenne.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity). (time frame: Baseline and 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2015.