NCT00103415

Brief Summary

During one year, 5-8% of the population will suffer from major depression. Some of the key symptoms are loss of interest in daily activities, loss of energy and sleeping disturbances. The financial consequences of this disease is estimated to be more than 30 million pounds per year in Great Britain and USA alone. There is an increasing interest in the effect exercise has on depression. Smaller studies indicate that exercise is a good treatment for depression. This study will be a large scale randomized trial and will hopefully bring important knowledge on the effects exercise has on depression. We will compare the effect endurance training, weight-lifting exercise and a control group has on depressive symptoms after 4 months training, twice a week.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

July 13, 2006

Status Verified

February 1, 2005

First QC Date

February 8, 2005

Last Update Submit

July 12, 2006

Conditions

Keywords

DepressionExerciseJob

Outcome Measures

Primary Outcomes (1)

  • HAMD-17

Secondary Outcomes (3)

  • Remission (<8 HAMD-17)

  • Response (50% reduction of score on HAMD-17)

  • Job situation

Interventions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-55
  • ICD-10 diagnoses F32.0, F32.1, F33.0, F33.1
  • Speak fluent danish

You may not qualify if:

  • Not able to do exercise
  • Drug/alcohol addict
  • The patient already engages in more than one hour of weekly exercise.
  • The patient has not been working the last 24 months due to depression.
  • Suicidal behavior.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric department, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • Krogh J, Saltin B, Gluud C, Nordentoft M. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression. J Clin Psychiatry. 2009 Jun;70(6):790-800. doi: 10.4088/jcp.08m04241.

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Endurance TrainingResistance Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Merete Nordentoft, M.D, Ph.D.

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

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

February 8, 2005

First Posted

February 9, 2005

Study Start

February 1, 2005

Study Completion

February 1, 2007

Last Updated

July 13, 2006

Record last verified: 2005-02

Locations