Treatment Resistant DepressionNCT01383811
Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
A study testing Moderate Intensity Aerobic Exercise and Wait-list in people with Treatment Resistant Depression, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Moderate Intensity Aerobic Exercise and Wait-list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2013
- 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
- Being sedentary (exercising less than 3 times/week for > 20 minutes at moderate/vigorous intensity for each bout)
- Ability to come for supervised exercises up to 5 days/week.
- On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
- Being able to read, understand, and provide written informed consent.
Who cannot join
- DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
- Behavioral or personality disturbances, which may significantly interfere with study participation.
- Evidence of acute suicidal risk.
- Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.
Read the detailed description
Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care. Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item). Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.
- Conditions
- Treatment Resistant Depression
- Being tested
- Moderate Intensity Aerobic Exercise, Wait-list
- Keywords
- Treatment Resistant Depression, Exercise
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Aerobic ExerciseOther
Also called Exercise, Aerobic Exercise
Individuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy). The moderate intensity exercise program will involve gradual progression in exercise intensity and duration. During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week. From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week. From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week. In total, the participants will be required to complete 150 minutes of moderate physical activity/week.
Wait-listOther
Also called Usual care, Care as usual, Standard Care
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Aerobic Exercise | Active comparator | Not described Receives: Other: Moderate Intensity Aerobic Exercise; Other: Wait-list |
| Wait List/Usual Care | Other | The subjects in this group will continue to receive the usual treatment that they were on at the time of enrollment through the wait list period of 12 weeks. Subsequently they will receive the 12 weeks of aerobic exercise program intervention Receives: Other: Wait-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (3)
Reduction in baseline scores of clinical global impression severity
Measured: Baseline, 6 weeks, and 12 weeks
Change from baseline on Beck Depression Inventory-II score
This is a widely used reliable and standardized measure of depression.
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score
PSQI is a widely used, reliable and standardized measure of subjecitve sleep
Measured: baseline, 6 weeks, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Ravi Singareddy, Milton S. Hershey Medical Center
- Investigators
- Ravi Singareddy, MD, Principal investigator, Penn State Univ. College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383811
- Sponsor's protocol ID
- 34749EP
- Status last verified
- Mar 2014
- First submitted
- 23 Jun 2011
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
- ClinicalTrials.gov ID
- NCT01383811
- Acronym / sponsor ID
- 34749EP
- Conditions
- Treatment Resistant Depression
- Keywords
- Treatment Resistant Depression, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jun 2011 (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.
The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.
Detailed description
Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care. Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item). Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Aerobic Exercise | Active comparator | Other: Moderate Intensity Aerobic Exercise, Other: Wait-list |
| Wait List/Usual Care | Other | Other: Wait-listThe subjects in this group will continue to receive the usual treatment that they were on at the time of enrollment through the wait list period of 12 weeks. Subsequently they will receive the 12 weeks of aerobic exercise program intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being sedentary (exercising less than 3 times/week for > 20 minutes at moderate/vigorous intensity for each bout)
- Ability to come for supervised exercises up to 5 days/week.
- On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
- Being able to read, understand, and provide written informed consent.
Key exclusion criteria (5 listed)
- DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
- Behavioral or personality disturbances, which may significantly interfere with study participation.
- Evidence of acute suicidal risk.
- Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
- Pregnancy.
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 |
|---|---|---|
| Moderate Intensity Aerobic ExerciseAlso: Exercise, Aerobic ExerciseIndividuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy). The moderate intensity exercise program will involve gradual progression in exercise intensity and duration. During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week. From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week. From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week. In total, the participants will be required to complete 150 minutes of moderate physical activity/week. | Other | Moderate Intensity Aerobic Exercise |
| Wait-listAlso: Usual care, Care as usual, Standard CareThe wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before. | Other | Moderate Intensity Aerobic Exercise, Wait List/Usual Care |
Primary outcome
Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
Time frame: Baseline, 6 weeks, and 12 weeks
Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.
3 secondary outcomes
Reduction in baseline scores of clinical global impression severity
Time frame: Baseline, 6 weeks, and 12 weeks
Change from baseline on Beck Depression Inventory-II score
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score
Time frame: baseline, 6 weeks, 12 weeks.
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 6 Mar 2014.
Related trials for Treatment Resistant Depression
Recruiting
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Depressive Disorder, Treatment-Resistant, Memory Deficits
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
RecruitingPhase 2
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Treatment-resistant Depression (TRD)
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
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.
Ravi Singareddy, MD principal investigator
Penn State Univ. College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Aerobic Exercise and Wait-list in people with Treatment Resistant Depression, run by Milton S. Hershey Medical Center at 1 site in United States.
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 4 inclusion and 5 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 6 Mar 2014. 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 United States. 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?
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?
Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score (time frame: Baseline, 6 weeks, and 12 weeks). 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 6 Mar 2014.