Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00021528 |
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Recruitment Status :
Completed
First Posted : July 23, 2001
Last Update Posted : September 25, 2009
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| Condition or disease | Intervention/treatment | 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 |
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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 (Clinical Trial) |
| Enrollment : | 4000 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Sequenced Treatment Alternatives to Relieve Depression |
| Study Start Date : | July 2001 |
| Study Completion Date : | September 2006 |
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021528
Hide Study 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 | |
| UCSD Outpatient Psychiatric Services | |
| San Diego, California, United States, 92103 | |
| Veterans Affairs Medical Center/FIRM Primary Care Clinic | |
| San Diego, California, United States, 92161 | |
| 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 | |
| Swampscott Family Doctors | |
| Boston, Massachusetts, United States, 01907 | |
| Internal Medicine Associates | |
| Boston, Massachusetts, United States, 02114 | |
| MGH/Charlestown Clinic | |
| Charlestown, Massachusetts, United States, 02129 | |
| MGH/Salem Professional | |
| Salem, Massachusetts, United States, 01970 | |
| United States, Michigan | |
| General Psychiatric Ambulatory Clinic | |
| Ann Arbor, Michigan, United States, 48105-0722 | |
| Briarwood Family Practice Clinic | |
| Ann Arbor, Michigan, United States, 48109-0708 | |
| 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 General Medicine Clinic | |
| Chapel Hill, North Carolina, United States, 27599-7110 | |
| UNC Chapel Hill Adult Diagnostic & Treatment Clinic | |
| Chapel Hill, North Carolina, United States, 27599-7160 | |
| UNC Chapel Hill Family Practice Clinic | |
| Chapel Hill, North Carolina, United States, 27955 | |
| United States, Oklahoma | |
| Springer Family Medicine | |
| Tulsa, Oklahoma, United States, 74135 | |
| Laureate Psychiatric Clinic & Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| Warren Clinic | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Diversified Human Services Clinic | |
| Pittsburgh, Pennsylvania, United States, 15062 | |
| Latterman Family Health Center | |
| Pittsburgh, Pennsylvania, United States, 15132 | |
| Bellefield Clinic of WPIC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| 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 | |
| The Holiner Psychiatric Group | |
| Dallas, Texas, United States, 75230 | |
| UT Southwestern Family Medicine Clinic | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| MCV Primary Care Clinic | |
| Richmond, Virginia, United States, 23220 | |
| MCV Family Counseling | |
| Richmond, Virginia, United States, 23298-0268 | |
| Study Director: | A. John Rush, MD | University of Texas Southwestern Medical Center Department of Psychiatry |
Additional Information:
Publications of Results:
Other Publications:
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 |
| First Posted: | July 23, 2001 Key Record Dates |
| Last Update Posted: | September 25, 2009 |
| Last Verified: | September 2006 |
Keywords provided by National Institute of Mental Health (NIMH):
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Sequential Treatment Major Depression Treatment Resistant Depression |
Additional relevant MeSH terms:
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Sertraline Citalopram Mirtazapine Nortriptyline Tranylcypromine Buspirone Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Antidepressive Agents, Tricyclic Histamine H1 Antagonists Histamine Antagonists Histamine Agents Anti-Anxiety Agents Tranquilizing Agents |