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Completed

NCT Number: NCT01383811

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

moderate intensity aerobic exercise

Other

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

Wait-list

Other

The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.

Other names: Usual care, Care as usual, Standard Care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Reduction in baseline scores of clinical global impression severity

    Time frame: Baseline, 6 weeks, and 12 weeks

  2. Change from baseline on Beck Depression Inventory-II score

    Time frame: Baseline, 6 weeks, 12 weeks

    This is a widely used reliable and standardized measure of depression.

  3. Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score

    Time frame: baseline, 6 weeks, 12 weeks.

    PSQI is a widely used, reliable and standardized measure of subjecitve sleep

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Penn State University

Registry information

Official study title

Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2011
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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