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Exercise in Treatment Resistant Depression (TRD): A Feasibility Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Ravi Singareddy, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01383811
First received: June 23, 2011
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Treatment Resistant Depression
 Other: Moderate Intensity Aerobic Exercise
Other: Wait-list

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score [ Time Frame: Baseline, 6 weeks, and 12 weeks ] [ Designated as safety issue: No ]
    Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.


Secondary Outcome Measures:
  • Reduction in baseline scores of clinical global impression severity [ Time Frame: Baseline, 6 weeks, and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline on Beck Depression Inventory-II score [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    This is a widely used reliable and standardized measure of depression.

  • Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score [ Time Frame: baseline, 6 weeks, 12 weeks. ] [ Designated as safety issue: No ]
    PSQI is a widely used, reliable and standardized measure of subjecitve sleep


Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moderate Intensity Aerobic Exercise Other: Moderate Intensity 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.
Other Names:
  • Exercise
  • Aerobic Exercise
Other: Wait-list
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Other Names:
  • Wait-list
  • Usual care
  • Care as usual
  • Standard Care
Wait List/Usual Care
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
 Other: Wait-list
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Other Names:
  • Wait-list
  • Usual care
  • Care as usual
  • Standard Care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383811

Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
Investigators
Principal Investigator: Ravi Singareddy, MD Penn State Univ. College of Medicine
  More Information

No publications provided

Responsible Party: Ravi Singareddy, Associate Proffesor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01383811     History of Changes
Other Study ID Numbers: 34749EP
Study First Received: June 23, 2011
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Treatment Resistant Depression
Exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013