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

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.

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.