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

NCT01383811 | Completed DMC

• 1 other identifier: 34749EP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression

Keywords

Treatment Resistant Depression; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (3)

• Reduction in baseline scores of clinical global impression severity

  Baseline, 6 weeks, and 12 weeks

• Change from baseline on Beck Depression Inventory-II score

  Baseline, 6 weeks, 12 weeks

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

  baseline, 6 weeks, 12 weeks.

Study Arms (2)

Moderate Intensity Aerobic Exercise

ACTIVE COMPARATOR

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

Other: Wait-list

Interventions

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.

Also known as: Exercise, Aerobic Exercise

Moderate Intensity Aerobic Exercise

Wait-list OTHER

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

Also known as: Usual care, Care as usual, Standard Care

Moderate Intensity Aerobic Exercise; Wait List/Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Penn State University: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Motor Activity

Interventions

Exercise; Waiting Lists; Standard of Care

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Appointments and Schedules; Organization and Administration; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Ravi Singareddy, MD

  Penn State Univ. College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

US (1)