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
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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:
MedlinePlus related topics:
Depression
Drug Information available for:
Liothyronine sodium
Nortriptyline
Lithium carbonate
Nortriptyline hydrochloride
Lithium citrate
Liothyronine
Tranylcypromine sulfate
Buspirone hydrochloride
Buspirone
Citalopram hydrobromide
Citalopram
Sertraline hydrochloride
Sertraline
Mirtazapine
Escitalopram oxalate
U.S. FDA Resources
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 |
Show Detailed Description 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021528
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Hide Study LocationsLocations
| 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 Citalopram Sertraline Nortriptyline Tranylcypromine Mirtazapine Dexetimide Buspirone Lithium Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013