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

March 5, 2014 updated by: Ravi Singareddy, Milton S. Hershey Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Standard Care
  • Usual care
  • Care as usual
Other: 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:
  • Standard Care
  • Usual care
  • Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in baseline scores of clinical global impression severity
Time Frame: Baseline, 6 weeks, and 12 weeks
Baseline, 6 weeks, and 12 weeks
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.
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.
PSQI is a widely used, reliable and standardized measure of subjecitve sleep
baseline, 6 weeks, 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Penn State University

Investigators

  • Principal Investigator: Ravi Singareddy, MD, Penn State Univ. College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34749EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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