This trial is active, not recruiting.

Condition depression
Treatment exercise
Phase phase 3
Sponsor National Institute of Mental Health (NIMH)
Start date April 2003
Trial size 122 participants
Trial identifier NCT00076258, DSIR 83-ATSO, R01 MH67692


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Treatment With Exercise Augmentation for Depression (TREAD)
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2007.
Information provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH).