Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464048
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2007-04-19
Brief Title:
A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will evaluate the effect of a short-term aerobic exercise program as an adjuvant treatment in patients with depression undergoing standard clinical antidepressant medication therapy as compared to the effect of stretching exercise In addition the effect of exercise on plasma biological markers will be examined and observed changes correlated with clinical antidepressant effects We hypothesize that the aerobic exercise group will achieve a significantly higher response rates of depressive symptoms will also have a greater degree of change in the plasma markers than the control stretching group
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None