Depression: Treatment with Exercise Augmentation for Depression (TrEAD)

Contact name: Dan Galper, Ph.D.

Phone: (214)-648-0168

Fax: (214)-648-1730

Email: Daniel.Galper@UTSouthwestern.edu

Disorder: Major Depressive Disorder (unipolar)

Geographic location: Dallas, Texas area

Other keywords: Depression, exercise, physical activity, SSRI antidepressant, cardiovascular disease

Participant compensation: $220 & Exercise-related incentives (e.g., heart rate monitor, step counter)

Time commitment required: 12-24 weeks (about 4 hours/week for exercise & assessments)

Drug trial: No

Recruitment end date (approximate): June 10, 2006

Study criteria (i.e., age or gender requirements):
INCLUSION CRITERIA
* Age 18 - 70 years (both men & women)
* Diagnosis of Major Depressive Disorder (MDD)
* Taking SSRI antidepressant, with 6 or more weeks at adequate dose
* Continued symptoms of depression while taking an SSRI
* Sedentary lifestyle
* Physically capable of exercise
* Willing and able to comply with study requirements

Exclusion criteria:
* Significant cardiovascular disease or other serious medical conditions
* Depression due to another condition/disorder, 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
* Abnormal exercise stress test
* Significantly elevated blood lipids
* Pregnancy (or planning to become pregnant in next year)

Brief description of study:
Partial response to antidepressant treatment is common in people with major depressive disorder (MDD) and is associated with reduced functioning and quality of life, as well as high risk for worsening of depressive symptoms. 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. TrEAD is evaluating the efficacy of exercise as an adjunctive treatment to selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have continued symptoms of depression despite drug treatment. Persons with MDD are also at increased risk for developing cardiovasular disease (CVD) and diabetes; therefore, TrEAD is also evaluating nove CVD risk factors among patients with MDD, as well as the relationship between symptoms of depression and CVD risk.

Additional information:
TrEAD, a collaborative study between UTSW and The Cooper Institute (Dallas, TX), is funded by the National Institute of Mental Health (Madhukar Trivedi, M.D., Principal Investigator). For further information, please go to our website: www.utsouthwestern.edu/utsw/cda/dept153392/files/203057.html