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A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00464048
First received: April 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Major Depressive Disorder
 Procedure: controlled physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Controlled Study to Assess the Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients With Major Depressive Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • response of depressive symptoms- reduction in HAM-D score at the end of the follow-up period

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: May 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Major Depressive Episode (MDE) in the context of MDD according to DSM-IV criteria, without psychotic features.
  2. Hamilton Depression Scale (21 items, HAM-D) total>14 with item 1 (depressed mood) >2.
  3. Physical capability to perform aerobic exercise or stretching exercise.
  4. Competent and willing to give written informed consent

Exclusion Criteria:

  1. Current, significant physical illness that will preclude exercise training.
  2. Any physical impairment that can interfere with exercise training.
  3. Current psychotic features.
  4. Treatment with electroconvulsive therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464048

Contacts
Contact: Tal Shahar, MD 00 972 2 6777181 taltal@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: tal Shahar, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00464048     History of Changes
Other Study ID Numbers: bhmi55-hmo-ctil
Study First Received: April 19, 2007
Last Updated: April 19, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013