NCT00076258

Brief Summary

This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2003

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2016

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

January 16, 2004

Results QC Date

November 17, 2015

Last Update Submit

September 1, 2020

Conditions

Depression

Keywords

Exercise therapyComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)

    The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).

    12 weeks

Study Arms (2)

SSRI+ LD

EXPERIMENTAL

A low dose aerobic exercise (LD) augmentation intervention to SSRI

Behavioral: SSRI + LD

SSRI+ PHD

EXPERIMENTAL

A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI

Behavioral: SSRI + PHD

Interventions

SSRI + LDBEHAVIORAL

Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.

SSRI+ LD
SSRI + PHDBEHAVIORAL

Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.

SSRI+ PHD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Major Depressive Disorder
  • Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
  • to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
  • Sedentary lifestyle
  • Physically capable of exercise
  • Body mass index (BMI) less than 40 kg/m2
  • Willing and able to comply with study requirements

You may not qualify if:

  • Significant cardiovascular disease or other medical conditions
  • Uncontrolled hypertension
  • Abnormal exercise stress test
  • Hematologic disorders
  • Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
  • Alcohol and/or substance abuse in the past 6 months
  • Hospitalization for mental illness within the past year
  • High suicide risk
  • Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
  • Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
  • Significantly elevated blood lipids
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (9)

  • Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct;23(5):584-603. doi: 10.1016/s0197-2456(02)00226-x.

    PMID: 12392873BACKGROUND

  • Dunn AL, Trivedi MH, O'Neal HA. Physical activity dose-response effects on outcomes of depression and anxiety. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S587-97; discussion 609-10. doi: 10.1097/00005768-200106001-00027.

    PMID: 11427783BACKGROUND

  • Crismon ML, Trivedi M, Pigott TA, Rush AJ, Hirschfeld RM, Kahn DA, DeBattista C, Nelson JC, Nierenberg AA, Sackeim HA, Thase ME. The Texas Medication Algorithm Project: report of the Texas Consensus Conference Panel on Medication Treatment of Major Depressive Disorder. J Clin Psychiatry. 1999 Mar;60(3):142-56.

    PMID: 10192589BACKGROUND

  • Galper DI, Trivedi MH, Barlow CE, Dunn AL, Kampert JB. Inverse association between physical inactivity and mental health in men and women. Med Sci Sports Exerc. 2006 Jan;38(1):173-8. doi: 10.1249/01.mss.0000180883.32116.28.

    PMID: 16394971BACKGROUND

  • Trivedi MH, Greer TL, Grannemann BD, Chambliss HO, Jordan AN. Exercise as an augmentation strategy for treatment of major depression. J Psychiatr Pract. 2006 Jul;12(4):205-13. doi: 10.1097/00131746-200607000-00002.

    PMID: 16883145BACKGROUND

  • Toups M, Carmody T, Greer T, Rethorst C, Grannemann B, Trivedi MH. Exercise is an effective treatment for positive valence symptoms in major depression. J Affect Disord. 2017 Feb;209:188-194. doi: 10.1016/j.jad.2016.08.058. Epub 2016 Oct 15.

    PMID: 27936452DERIVED

  • Suterwala AM, Rethorst CD, Carmody TJ, Greer TL, Grannemann BD, Jha M, Trivedi MH. Affect Following First Exercise Session as a Predictor of Treatment Response in Depression. J Clin Psychiatry. 2016 Aug;77(8):1036-42. doi: 10.4088/JCP.15m10104.

    PMID: 27561137DERIVED

  • Rethorst CD, Sunderajan P, Greer TL, Grannemann BD, Nakonezny PA, Carmody TJ, Trivedi MH. Does exercise improve self-reported sleep quality in non-remitted major depressive disorder? Psychol Med. 2013 Apr;43(4):699-709. doi: 10.1017/S0033291712001675. Epub 2012 Aug 29.

    PMID: 23171815DERIVED

  • Trivedi MH, Greer TL, Church TS, Carmody TJ, Grannemann BD, Galper DI, Dunn AL, Earnest CP, Sunderajan P, Henley SS, Blair SN. Exercise as an augmentation treatment for nonremitted major depressive disorder: a randomized, parallel dose comparison. J Clin Psychiatry. 2011 May;72(5):677-84. doi: 10.4088/JCP.10m06743.

    PMID: 21658349DERIVED

MeSH Terms

Conditions

Depression

Interventions

Selective Serotonin Reuptake Inhibitorsphosducin

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Results Point of Contact

Title
Madhukar H Trivedi
Organization
UT Southwestern Medical Center
madhukar.trivedi@utsouthwestern.edu
214-648-0188

Study Officials

  • Madhukar Trivedi, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Professor of Psychiatry

Study Record Dates

First Submitted

January 16, 2004

First Posted

January 19, 2004

Study Start

April 1, 2003

Primary Completion

October 1, 2006

Study Completion

August 1, 2007

Last Updated

September 23, 2020

Results First Posted

December 7, 2016

Record last verified: 2020-09

Locations

US(1)