Adding Exercise to Antidepressant Medication Treatment for Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00076258
First received: January 16, 2004
Last updated: July 5, 2007
Last verified: July 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Treatment With Exercise Augmentation for Depression (TREAD)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00076258     History of Changes
Other Study ID Numbers: R01 MH67692, DSIR 83-ATSO
Study First Received: January 16, 2004
Last Updated: July 5, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Exercise therapy
Complementary Therapies

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014