Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00021528
First received: July 20, 2001
Last updated: September 24, 2009
Last verified: September 2006
  Purpose

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


Condition Intervention Phase
Depression
Drug: citalopram
Drug: BuproprionSR
Drug: buspirone
Drug: Lithium
Drug: mirtazapine
Drug: nortriptyline
Drug: sertraline
Drug: tranylcypromine
Drug: VenlafaxineXR
Behavioral: Cognitive Therapy
Drug: T3 (Triiodothyronine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequenced Treatment Alternatives to Relieve Depression

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 4000
Study Start Date: July 2001
Estimated Study Completion Date: September 2006
  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021528

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

Additional Information:
Publications:
Gilmer WS, Kemp DE. STAR*D: What Have We Learned Thus Far? International Drug Therapy Newsletter 41:75-82, 2006.
Friedman EF, Thase ME, Biggs MM, Carmin C, Hollon SD, Kornblith SJ, Petersen T, Veenstra G, Wisniewski SR, and Rush AJ. The implementation of cognitive therapy in STAR*D. Cognitive Therapy and Research, 28:819-833, 2004.
Gaynes, B.N., Davis, L., Rush A.J., Trivedi, M., Fava, M., Wisniewski, S.R. The aims and design of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Primary Psychiatry, 12(2):36-41, 2005.
Friedman EF, Thase ME, Biggs MM, Carmin C, Hollon SD, Kornblith SJ, Petersen T, Veenstra G, Wisniewski SR, Rush AJ. The implementation of cognitive therapy in STAR*D. Cognit Ther Res 2004;28:819-33.

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

ClinicalTrials.gov Identifier: NCT00021528     History of Changes
Other Study ID Numbers: N01 MH90003, DSIR AT
Study First Received: July 20, 2001
Last Updated: September 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Sequential Treatment
Major Depression
Treatment Resistant Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nortriptyline
Tranylcypromine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 18, 2014