Adding Exercise to Antidepressant Medication Treatment for Depression (TREAD)

The University of Texas System (UT)

Status

Completed

Conditions

Depression

Treatments

Behavioral: SSRI + PHD

Behavioral: SSRI + LD

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00076258

R01MH067692-01 (U.S. NIH Grant/Contract)

STU 092010-032

Details and patient eligibility

About

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

Full 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.

Enrollment

126 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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