Clinical Trial: Adding Exercise to Antidepressant Medication Treatment for Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

Condition Treatment or Intervention Phase
Depression
 Behavior: Exercise
Phase III

MedlinePlus related topics:  Depression

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: 

Expected Total Enrollment:  122

Study start: April 2003

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   -   70 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


Texas
      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  75235,  United States; Recruiting
Daniel I. Galper, PhD  469-441-0186    Daniel.Galper@UTSouthwestern.edu 
Tracy Greer, PhD  214-648-0156    Tracy.Greer@UTSouthwestern.edu 
Madhukar H. Trivedi, MD,  Principal Investigator
Andrea Dunn, PhD,  Sub-Investigator
Daniel I. Galper, PhD,  Sub-Investigator
Tracy Greer, PhD,  Sub-Investigator

More Information

Cooper Institute - a nonprofit research and education center

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.

Study ID Numbers:  MH67692-01; 1 R01 MH0676692-01
Record last reviewed:  February 2005
Last Updated:  February 10, 2005
Record first received:  January 16, 2004
ClinicalTrials.gov Identifier:  NCT00076258
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005