Adding Exercise to Antidepressant Medication Treatment for Depression - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00076258

Purpose

This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

Condition	Intervention	Phase
Depression	Behavioral: Exercise	Phase III

MedlinePlus related topics: Antidepressants Depression Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Treatment With Exercise Augmentation for Depression (TREAD)

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	122
Study Start Date:	April 2003

Detailed Description:

Partial response to antidepressant treatment is common in people with MDD and is associated with significant morbidity and reduced quality of life. Pharmacological therapies have been used to augment the effect of antidepressants; however, such therapies are associated with a range of adverse effects. Studies indicate that exercise may be safe and effective in augmenting depression treatment. This study will determine whether exercise can complement selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have residual symptoms of depression despite drug treatment.

Participants will be randomly assigned to either high frequency exercise or low frequency exercise for 12 weeks. Depression symptoms will be measured weekly. Quality of life and satisfaction with the study will also be measured. Depression scales and self-reports will be used to assess participants.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Major Depressive Disorder
Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
Sedentary lifestyle
Physically capable of exercise
Body mass index (BMI) less than 40 kg/m2
Willing and able to comply with study requirements

Exclusion Criteria:

Significant cardiovascular disease or other medical conditions
Uncontrolled hypertension
Abnormal exercise stress test
Hematologic disorders
Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
Alcohol and/or substance abuse in the past 6 months
Hospitalization for mental illness within the past year
High suicide risk
Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
Significantly elevated blood lipids
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076258

Locations

United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Cooper Institute - a nonprofit research and education center This link exits the ClinicalTrials.gov site

Publications:

Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct; 23(5): 584-603.

Dunn AL, Trivedi MH, O'Neal HA. Physical activity dose-response effects on outcomes of depression and anxiety. Med Sci Sports Exerc. 2001 Jun; 33(6 Suppl): S587-97; discussion 609-10. Review.

Crismon ML, Trivedi M, Pigott TA, Rush AJ, Hirschfeld RM, Kahn DA, DeBattista C, Nelson JC, Nierenberg AA, Sackeim HA, Thase ME. The Texas Medication Algorithm Project: report of the Texas Consensus Conference Panel on Medication Treatment of Major Depressive Disorder. J Clin Psychiatry. 1999 Mar; 60(3): 142-56. Review.

Galper DI, Trivedi MH, Barlow CE, Dunn AL, Kampert JB. Inverse association between physical inactivity and mental health in men and women. Med Sci Sports Exerc. 2006 Jan;38(1):173-8.

Trivedi MH, Greer TL, Grannemann BD, Chambliss HO, Jordan AN. Exercise as an augmentation strategy for treatment of major depression. J Psychiatr Pract. 2006 Jul;12(4):205-13.

Study ID Numbers:	R01 MH67692, DSIR 83-ATSO
Study First Received:	January 16, 2004
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00076258
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Exercise therapy
Complementary Therapies

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009