Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

September 24, 2009 updated by: National Institute of Mental Health (NIMH)

Sequenced Treatment Alternatives to Relieve Depression

STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The STAR*D project will enroll 4,000 outpatients (ages 18 -75) diagnosed with nonpsychotic Major Depressive Disorder. Participants will be initially treated (open label) with citalopram, the Level 1 treatment, for a minimum of 8 weeks. Patients who experience minimal benefit will be strongly encouraged to complete 12 weeks of treatment in order to maximize the chances of symptom remission (unless no benefit at all is seen after 8 weeks). All participants will also receive a brief depression educational program.

At each level change, participants will be asked to indicate the unacceptability of the potential treatment strategies (e.g, to augment or to switch medications). Participants will then be eligible for random assignment to one of the acceptable and medically safe treatment options.

Level 2: Participants who either did not have an adequate response to or could not tolerate citalopram are eligible for Level 2. The Level 2 treatment strategies are:

i) Medication and Psychotherapy Switch: switch to sertraline, venlafaxineXR, bupropionSR, or cognitive therapy (CT).

ii) Medication and Psychotherapy Augmentation: add to citalopram either a) buspirone, b) bupropionSR, or c) CT.

iii) Medication Only Switch or Medication Only Augmentation options are available for participants for whom CT is unacceptable.

iv)Psychotherapy Only Switch or Psychotherapy Only Augmentation options are available for participants for whom additional medication is unacceptable at this point in the study (participants must be willing to continue citalopram)

Level 2A: Participants without a satisfactory response to their Level 2 treatment are eligible for random assignment to additional treatment at Level 2A (if medically safe and acceptable). Level 2A is included so that all participants entering Level 3 have had an opportunity to respond to at least 2 medications. Level 2A consists of Medication Switch to one of two antidepressant medications (venlafaxineXR or bupropion SR).

Level 3: Participants without satisfactory response to Level 2 and,if appropriate Level 2A, are eligible for random assignment to one of the following treatments (if acceptable and medically safe):

i) Medication Switch to: a) mirtazapine or b) nortriptyline, a tricyclic antidepressant.

ii) Medication Augmentation: Add (to current Level 2 or Level 2A medication) either: a) lithium or b) thyroid hormone (T3).

Level 4: Participants without an adequate response to Level 3 are eligible for random assignment to Level 4 treatment (if acceptable and medically safe). Level 4 includes two Medication Switch options: to tranylcypromine [a monoamine oxidase inhibitor (MAOI)], or to mirtazapine plus venlafaxineXR.

After Level 4, participants without an adequate response will discuss other acceptable treatment options with their physician.

Once an adequate response is achieved at Levels 2, 2A, 3 or 4, participants are eligible to enter the 12-month follow-up, during which time they will remain on their current treatment(s) and will be asked about their symptoms and other relevant information monthly by telephone. ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY.

Study Type

Interventional

Enrollment

4000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35223
        • Birmingham VA Medical Center
      • Tuscaloosa, Alabama, United States, 35404
        • Tuscaloosa VA Mental Health Clinic - Veterans Only
      • Tuscaloosa, Alabama, United States, 35404
        • Tuscaloosa VA Primary Care Center
    • California
      • Chula Vista, California, United States, 91910
        • Psychiatric Centers at San Diego
      • Harbor City, California, United States, 90710
        • Harbor UCLA Family Health Care Center
      • Los Angeles, California, United States, 90024
        • UCLA Internal Medicine Clinic
      • Los Angeles, California, United States, 90024
        • UCLA General Outpatient Psychiatry Clinic
      • San Diego, California, United States, 92103
        • UCSD Outpatient Psychiatric Services
      • San Diego, California, United States, 92161
        • Veterans Affairs Medical Center/FIRM Primary Care Clinic
      • Torrance, California, United States, 90509
        • Harbor Ucla Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Outpatient Treatment Care Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago Clinic
      • Evanston, Illinois, United States, 60201
        • Evanston Outpatient Clinic
    • Kansas
      • Wichita, Kansas, United States, 67203
        • COMCARE of Sedgwick County
      • Wichita, Kansas, United States, 67214-2878
        • Psychiatric Outpatient Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 01907
        • Swampscott Family Doctors
      • Boston, Massachusetts, United States, 02114
        • Internal Medicine Associates
      • Charlestown, Massachusetts, United States, 02129
        • MGH/Charlestown Clinic
      • Salem, Massachusetts, United States, 01970
        • MGH/Salem Professional
    • Michigan
      • Ann Arbor, Michigan, United States, 48105-0722
        • General Psychiatric Ambulatory Clinic
      • Ann Arbor, Michigan, United States, 48109-0708
        • Briarwood Family Practice Clinic
    • New York
      • Glen Oaks, New York, United States, 11004
        • LIJ/Zucker Hillside Adult Ambulatory Care Center
      • Lake Success, New York, United States, 11040
        • LIJ North Shore Medical Group
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7160
        • UNC Chapel Hill Adult Diagnostic & Treatment Clinic
      • Chapel Hill, North Carolina, United States, 27599-7110
        • UNC Chapel Hill General Medicine Clinic
      • Chapel Hill, North Carolina, United States, 27955
        • UNC Chapel Hill Family Practice Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Springer Family Medicine
      • Tulsa, Oklahoma, United States, 74136
        • Laureate Psychiatric Clinic & Hospital
      • Tulsa, Oklahoma, United States, 74136
        • Warren Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Bellefield Clinic of WPIC
      • Pittsburgh, Pennsylvania, United States, 15062
        • Diversified Human Services Clinic
      • Pittsburgh, Pennsylvania, United States, 15132
        • Latterman Family Health Center
      • Upper St. Clair, Pennsylvania, United States, 15317
        • AMPN Corkery, Heise & Dainesi
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vine Hill Community Clinic
      • Nashville, Tennessee, United States, 37203
        • Psychiatric Consultants, P.C.
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center-Mental Health Center
      • Nashville, Tennessee, United States, 37217
        • Centerstone/Luton Mental Health Services
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Family Medicine Clinic
      • Dallas, Texas, United States, 75230
        • The Holiner Psychiatric Group
    • Virginia
      • Richmond, Virginia, United States, 23220
        • MCV Primary Care Clinic
      • Richmond, Virginia, United States, 23298-0268
        • MCV Family Counseling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

- Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • Study Director: A. John Rush, MD, University of Texas Southwestern Medical Center Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

July 20, 2001

First Submitted That Met QC Criteria

July 21, 2001

First Posted (Estimate)

July 23, 2001

Study Record Updates

Last Update Posted (Estimate)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH90003
  • DSIR AT (NCT00590863)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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