A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00464048|
Recruitment Status : Unknown
Verified April 2007 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : April 20, 2007
Last Update Posted : April 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Procedure: controlled physical exercise||Not Applicable|
The patients will be randomly assigned to 3 weeks of augmentation therapy (in addition to the antidepressant medication, which will be continued) with either: 1) aerobic exercise or 2) stretching exercise (control group). Random assignment to each group will be stratified according to previous response to treatment as determined by a psychiatrist and review of the Antidepressant Treatment History Form (ATHF) and by gender.
Severity of depression will be rated at the first baseline visit and every week during the exercise program using the Hamilton Depression Scale (HAM-D 21 items), Clinical Global Impression Scale (CGI) (observer-rated) and Beck Depression Inventory (BDI) and Visual Analog Scale (self-rated).
Blood samples will be obtained four times during the study - before and after the first exercise session and before and after the last exercise session. The blood taken before the exercise sessions will be used to assay thyroxine, cortisol, insulin, opioid peptides and cytokines such as IL-6 and TNF-α in the plasma. The blood taken after the exercise sessions will be used to re-examine variables expected to be altered immediately after exercise such as cortisol, opioid peptides, catecholamines and cytokines.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||May 2009|
- response of depressive symptoms- reduction in HAM-D score at the end of the follow-up period
- reduction in pretreatment BDI score
- remission according to HAM-D score
- remission according to BDI score
- changes in plasmatic measurements before and after the first and last exercise
- length of hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464048
|Contact: Tal Shahar, MD||00 972 2 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||00 972 2 email@example.com|
|Principal Investigator:||tal Shahar, MD||Hadassah Medical Organization|