Clinical trial NCT01383811: 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
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Keywords: Treatment Resistant Depression
Exercise
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2011-06-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
timeFrame: Baseline, 6 weeks, and 12 weeks
Secondary outcomes:
measure: Reduction in baseline scores of clinical global impression severity
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Change from baseline on Beck Depression Inventory-II score
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score
timeFrame: baseline, 6 weeks, 12 weeks.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Univ. College of Medicine
name: Ravi Singareddy, MD
role: PRINCIPAL_INVESTIGATOR
References: