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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study

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 Summary: 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.
Sponsor: Milton S. Hershey Medical Center

Current Primary Outcome: Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score [ Time Frame: Baseline, 6 weeks, and 12 weeks ]

Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in baseline scores of clinical global impression severity [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
  • Change from baseline on Beck Depression Inventory-II score [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    This is a widely used reliable and standardized measure of depression.
  • Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score [ Time Frame: baseline, 6 weeks, 12 weeks. ]
    PSQI is a widely used, reliable and standardized measure of subjecitve sleep


Original Secondary Outcome: Same as current

Information By: Milton S. Hershey Medical Center

Dates:
Date Received: June 23, 2011
Date Started: June 2011
Date Completion:
Last Updated: March 5, 2014
Last Verified: March 2014