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

Primary Purpose

Treatment Resistant Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Intensity Aerobic Exercise
Wait-list
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Treatment Resistant Depression, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Moderate Intensity Aerobic Exercise

Wait List/Usual Care

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reduction in baseline scores of clinical global impression severity
Change from baseline on Beck Depression Inventory-II score
This is a widely used reliable and standardized measure of depression.
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

Full Information

First Posted
June 23, 2011
Last Updated
March 5, 2014
Sponsor
Milton S. Hershey Medical Center
Collaborators
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT01383811
Brief Title
Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
Official Title
Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
Treatment Resistant Depression, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Intensity Aerobic Exercise
Arm Type
Active Comparator
Arm Title
Wait List/Usual Care
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Aerobic Exercise
Other Intervention Name(s)
Exercise, Aerobic Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wait-list
Other Intervention Name(s)
Usual care, Care as usual, Standard Care
Intervention Description
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Primary Outcome Measure Information:
Title
Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
Description
Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.
Time Frame
Baseline, 6 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Reduction in baseline scores of clinical global impression severity
Time Frame
Baseline, 6 weeks, and 12 weeks
Title
Change from baseline on Beck Depression Inventory-II score
Description
This is a widely used reliable and standardized measure of depression.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score
Description
PSQI is a widely used, reliable and standardized measure of subjecitve sleep
Time Frame
baseline, 6 weeks, 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Singareddy, MD
Organizational Affiliation
Penn State Univ. College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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

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