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

Treatment Resistant Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383811
• Other study ID #: 34749EP
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: March 5, 2014
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Other:
• Moderate Intensity Aerobic Exercise
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.
• Wait-list
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reduction in baseline scores of clinical global impression severity		Baseline, 6 weeks, and 12 weeks	No
Secondary	Change from baseline on Beck Depression Inventory-II score	This is a widely used reliable and standardized measure of depression.	Baseline, 6 weeks, 12 weeks	No
Secondary	Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score	PSQI is a widely used, reliable and standardized measure of subjecitve sleep	baseline, 6 weeks, 12 weeks.	No