Depressed Adolescents Treated With Exercise (The DATE Study)

NCT00847457 | Completed DMC

• 2 other identifiers: R34MH075762DSIR 84-CTCT
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate whether standardized aerobic exercise is an effective treatment for depression in adolescents.

Conditions

Depression

Keywords

Exercise; Stretching; Adolescents

Outcome Measures

Primary Outcomes (1)

• Childrens Depression Rating Scale - Revised (CDRS-R)

  Measured after 12 weeks, 6 months, and 12 months

Secondary Outcomes (2)

• Exercise feasibility and adherence

  Measured after 12 weeks

• Amount of energy expended, as measured by the Actical monitor

  Measured after 12 weeks

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Participants will perform aerobic exercise regularly for 12 weeks.

Behavioral: Aerobic exercise

Stretch

ACTIVE COMPARATOR

Participants will stretch regularly for 12 weeks.

Behavioral: Stretching

Interventions

Aerobic exercise BEHAVIORAL

Aerobic exercises completed three to four times per week for 20 to 30 minutes per session

Aerobic exercise

Stretching BEHAVIORAL

Easy to moderate stretching routines completed three times per week, with a new set of routines given each week

Stretch

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
• Clinical Global Impression-Severity (CGI-S) score of 4 or greater
• Children's Depression Rating Scale (CDRS) score of greater than 35 but less than 71
• Currently attending school
• Willing and able to use acceptable methods of contraception, if applicable
• A signed letter from family physician verifying physical health necessary for participation in the exercise program
• Response to the Physical Activity Readiness Questionnaire (PAR-Q) indicates that no conditions are present that would render exercise inappropriate
• Speaks and reads English
• Parent or guardian willing to provide informed consent, if applicable

You may not qualify if:

• Severe suicidal ideation
• History of psychotic disorders
• Alcohol or substance abuse or dependence within 6 months of study entry
• History of anorexia nervosa or bulimia
• Chronic medical illness requiring regular medication
• Pregnant
• Currently participating in a vigorous exercise program or activity, defined as 30 minutes of vigorous physical activity five times per week
• IQ less than 70

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (1)

• Hughes CW, Trivedi MH, Cleaver J, Greer TL, Emslie GJ, Kennard B, Dorman S, Bain T, Dubreuil J, Barnes C. DATE: Depressed adolescents treated with exercise: Study rationale and design for a pilot study. Ment Health Phys Act. 2009 Dec;2(2):76-85. doi: 10.1016/j.mhpa.2009.09.005.

  PMID: 20454641 BACKGROUND

MeSH Terms

Conditions

Depression; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carroll W. Hughes, PhD, ABPP

  University of Texas Southwestern Medical Center - Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 27, 2013

Record last verified: 2013-06