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

Penn State Health

Status: Completed

Conditions: Treatment Resistant Depression

Treatments: Other: Moderate Intensity Aerobic Exercise; Other: Wait-list

Study type: Interventional

Funder types: Other

Identifiers

NCT01383811

34749EP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Moderate Intensity Aerobic Exercise

Active Comparator group

Treatment:

Other: Wait-list

Other: Moderate Intensity Aerobic Exercise

Wait List/Usual Care

Other group

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

Treatment:

Other: Wait-list