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The Effect of Exercise on Depressive Symptoms in Unmedicated Patients (DEMOII)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00695552
First received: June 10, 2008
Last updated: March 17, 2010
Last verified: June 2008
History of Changes
  Purpose

This trial investigates the biological effect of exercise training on depression. Participants will randomly be allocated to either a aerobic exercise group performing exercise on stationary bikes or a group performing low-impact exercise such as stretching exercises. Both groups will attend sessions three times per week for 3 months. Before and after the intervention the investigators will measure the severity of depression using the Hamilton depression rating scale (HAM-D17).


Condition Intervention
Major Depression
 Behavioral: Aerobic exercise
Behavioral: Low impact exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DEMO II: A Randomized, Parallel-group, Observer-blinded Clinical Trial of Aerobic Exercise Versus Stretching Exercise for Patients With Light to Moderate Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • HAM-D17 [ Time Frame: Before and after 3 months intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission from depression (not fulfilling the DSM-IV criteria for depression and a hamilton rating below 8) [ Time Frame: Before and after 3 months intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aerobic exercise on stationary bikes. Three sessions/week for 3 three months. First month the workload is equivalent to 65% of HRmax, the second month the workload is equivalent to 70% of HRmax, and the third month the workload is equivalent to 75% of HRmax
 Behavioral: Aerobic exercise
Aerobic exercise on stationary bikes. Three sessions/week for 3 three months. First month the workload is equivalent to 65% of HRmax, the second month the workload is equivalent to 70% of HRmax, and the third month the workload is equivalent to 75% of HRmax
Other Name: Aerobic exercise
Placebo Comparator: 2
Participants meets 3 times/week for 3 months. They will engage in low impact activities such as stretching exercises.
 Behavioral: Low impact exercise
Participants meets 3 times/week for 3 months. They will engage in low impact activities such as stretching exercises
Other Name: low impact exercise

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 - 60 years
  2. Major depression according to DSM-IV
  3. Living within 30 km of training facilities
  4. Able to read and understand informed consent

Exclusion Criteria:

  1. Recreational or current drug abuse
  2. Having used antidepressant medication within the last 2 months
  3. Contraindications to physical exercise
  4. Recreational exercise> 1 hour per week
  5. Medication for diabetes, hypertension, or any kidney disease
  6. Suicidal behaviour (ham-d17 item3 > 2)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695552

Contacts
Contact: Jesper Krogh, M.D +45 2615 3753 jk27@bbh.hosp.dk

Locations
Denmark
Psychiatric Center Bispebjerg Recruiting
Copenhagen, Denmark, 2400
Contact: Jesper Krogh, M.D     + 45 2615 3753     jk27@bbh.regionh.dk    
Principal Investigator: Jesper Krogh, M.D            
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Jesper Krogh, M.D Psychiatric Center Bispebjerg, Bispebjerg University Hospital, Copenhagen Denmark
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jesper Krogh, M.D (principal investigator), Psychiatic Center Bispebjerg
ClinicalTrials.gov Identifier: NCT00695552     History of Changes
Other Study ID Numbers: DEMOII
Study First Received: June 10, 2008
Last Updated: March 17, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Major depression, exercise

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

ClinicalTrials.gov processed this record on May 16, 2013