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

NCT00464048 | Unknown

• 1 other identifier: bhmi55-hmo-ctil
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

controlled physical exercise PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current, significant physical illness that will preclude exercise training.
• Any physical impairment that can interfere with exercise training.
• Current psychotic features.
• Treatment with electroconvulsive therapy.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• tal Shahar, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Shahar, MD

CONTACT

00 972 2 6777181; taltal@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572; lhadas@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: May 1, 2007
• Study Completion: May 1, 2009
• Last Updated: April 20, 2007

Record last verified: 2007-04

Locations

IL (1)