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Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Information source: National Institute of Mental Health (NIMH)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: citalopram (Drug); BuproprionSR (Drug); buspirone (Drug); Lithium (Drug); mirtazapine (Drug); nortriptyline (Drug); sertraline (Drug); tranylcypromine (Drug); VenlafaxineXR (Drug); Cognitive Therapy (Behavioral); T3 (Triiodothyronine) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
A. John Rush, MD, Study Director, Affiliation: University of Texas Southwestern Medical Center Department of Psychiatry

Summary

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

Clinical Details

Official title: Sequenced Treatment Alternatives to Relieve Depression

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

- Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD

score 14 or greater)

Locations and Contacts

Birmingham VA Medical Center, Birmingham, Alabama 35223, United States

Tuscaloosa VA Mental Health Clinic - Veterans Only, Tuscaloosa, Alabama 35404, United States

Tuscaloosa VA Primary Care Center, Tuscaloosa, Alabama 35404, United States

Psychiatric Centers at San Diego, Chula Vista, California 91910, United States

Harbor UCLA Family Health Care Center, Harbor City, California 90710, United States

UCLA General Outpatient Psychiatry Clinic, Los Angeles, California 90024, United States

UCLA Internal Medicine Clinic, Los Angeles, California 90024, United States

UCSD Outpatient Psychiatric Services, San Diego, California 92103, United States

Veterans Affairs Medical Center/FIRM Primary Care Clinic, San Diego, California 92161, United States

Harbor UCLA Medical Center, Torrance, California 90509, United States

Northwestern Outpatient Treatment Care Center, Chicago, Illinois 60611, United States

University of Illinois at Chicago Clinic, Chicago, Illinois 60612, United States

Evanston Outpatient Clinic, Evanston, Illinois 60201, United States

COMCARE of Sedgwick County, Wichita, Kansas 67203, United States

Psychiatric Outpatient Clinic, Wichita, Kansas 67214-2878, United States

Internal Medicine Associates, Boston, Massachusetts 02114, United States

Swampscott Family Doctors, Boston, Massachusetts 01907, United States

MGH/Charlestown Clinic, Charlestown, Massachusetts 02129, United States

MGH/Salem Professional, Salem, Massachusetts 01970, United States

Briarwood Family Practice Clinic, Ann Arbor, Michigan 48109-0708, United States

General Psychiatric Ambulatory Clinic, Ann Arbor, Michigan 48105-0722, United States

LIJ/Zucker Hillside Adult Ambulatory Care Center, Glen Oaks, New York 11004, United States

LIJ North Shore Medical Group, Lake Success, New York 11040, United States

UNC Chapel Hill Adult Diagnostic & Treatment Clinic, Chapel Hill, North Carolina 27599-7160, United States

UNC Chapel Hill Family Practice Clinic, Chapel Hill, North Carolina 27955, United States

UNC Chapel Hill General Medicine Clinic, Chapel Hill, North Carolina 27599-7110, United States

Laureate Psychiatric Clinic & Hospital, Tulsa, Oklahoma 74136, United States

Springer Family Medicine, Tulsa, Oklahoma 74135, United States

Warren Clinic, Tulsa, Oklahoma 74136, United States

Bellefield Clinic of WPIC, Pittsburgh, Pennsylvania 15213, United States

Diversified Human Services Clinic, Pittsburgh, Pennsylvania 15062, United States

Latterman Family Health Center, Pittsburgh, Pennsylvania 15132, United States

AMPN Corkery, Heise & Dainesi, Upper St. Clair, Pennsylvania 15317, United States

Centerstone/Luton Mental Health Services, Nashville, Tennessee 37217, United States

Psychiatric Consultants, P.C., Nashville, Tennessee 37203, United States

Vanderbilt University Medical Center-Mental Health Center, Nashville, Tennessee 37212, United States

Vine Hill Community Clinic, Nashville, Tennessee 37212, United States

The Holiner Psychiatric Group, Dallas, Texas 75230, United States

UT Southwestern Family Medicine Clinic, Dallas, Texas 75390, United States

MCV Family Counseling, Richmond, Virginia 23298-0268, United States

MCV Primary Care Clinic, Richmond, Virginia 23220, United States

Additional Information

Click here for more information about this study

More information on depression

NIMH STAR*D Study Results

Related publications:

Adli M, Rush AJ, Möller HJ, Bauer M. Algorithms for optimizing the treatment of depression: making the right decision at the right time. Pharmacopsychiatry. 2003 Nov;36 Suppl 3:S222-9. Review.

Fava M, Rush AJ, Trivedi MH, Nierenberg AA, Thase ME, Sackeim HA, Quitkin FM, Wisniewski S, Lavori PW, Rosenbaum JF, Kupfer DJ. Background and rationale for the sequenced treatment alternatives to relieve depression (STAR*D) study. Psychiatr Clin North Am. 2003 Jun;26(2):457-94, x. Review.

Rush AJ, Trivedi M, Fava M. Depression, IV: STAR*D treatment trial for depression. Am J Psychiatry. 2003 Feb;160(2):237.

Lavori PW, Rush AJ, Wisniewski SR, Alpert J, Fava M, Kupfer DJ, Nierenberg A, Quitkin FM, Sackeim HA, Thase ME, Trivedi M. Strengthening clinical effectiveness trials: equipoise-stratified randomization. Biol Psychiatry. 2001 Nov 15;50(10):792-801.

Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, Thase ME, Nierenberg AA, Quitkin FM, Kashner TM, Kupfer DJ, Rosenbaum JF, Alpert J, Stewart JW, McGrath PJ, Biggs MM, Shores-Wilson K, Lebowitz BD, Ritz L, Niederehe G; STAR*D Investigators Group. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004 Feb;25(1):119-42.

Wisniewski SR, Stegman D, Trivedi M, Husain MM, Eng H, Shores-Wilson K, Luther J, Biggs MM, Burroughs D, Ritz AL, Fava M, Quitkin F, Rush AJ; STAR*D Investigators. Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D). J Psychiatr Res. 2004 May-Jun;38(3):241-8.

Wisniewski SR, Eng H, Meloro L, Gatt R, Ritz L, Stegman D, Trivedi M, Biggs MM, Friedman E, Shores-Wilson K, Warden D, Bartolowits D, Martin JP, Rush AJ. Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project. Clin Trials. 2004;1(4):387-98.

Nierenberg AA, Trivedi MH, Ritz L, Burroughs D, Greist J, Sackeim H, Kornstein S, Schwartz T, Stegman D, Fava M, Wisniewski SR. Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. J Psychiatr Res. 2004 Nov-Dec;38(6):583-9.

Yates WR, Mitchell J, Rush AJ, Trivedi MH, Wisniewski SR, Warden D, Hauger RB, Fava M, Gaynes BN, Husain MM, Bryan C. Clinical features of depressed outpatients with and without co-occurring general medical conditions in STAR*D. Gen Hosp Psychiatry. 2004 Nov-Dec;26(6):421-9.

Fava M, Alpert JE, Carmin CN, Wisniewski SR, Trivedi MH, Biggs MM, Shores-Wilson K, Morgan D, Schwartz T, Balasubramani GK, Rush AJ. Clinical correlates and symptom patterns of anxious depression among patients with major depressive disorder in STAR*D. Psychol Med. 2004 Oct;34(7):1299-308.

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.

Zisook S, Rush AJ, Albala A, Alpert J, Balasubramani GK, Fava M, Husain M, Sackeim H, Trivedi M, Wisniewski S. Factors that differentiate early vs. later onset of major depression disorder. Psychiatry Res. 2004 Dec 15;129(2):127-40.

Davis LL, Rush JA, Wisniewski SR, Rice K, Cassano P, Jewell ME, Biggs MM, Shores-Wilson K, Balasubramani GK, Husain MM, Quitkin FM, McGrath PJ. Substance use disorder comorbidity in major depressive disorder: an exploratory analysis of the Sequenced Treatment Alternatives to Relieve Depression cohort. Compr Psychiatry. 2005 Mar-Apr;46(2):81-9.

Perlis RH, Fraguas R, Fava M, Trivedi MH, Luther JF, Wisniewski SR, Rush AJ. Prevalence and clinical correlates of irritability in major depressive disorder: a preliminary report from the Sequenced Treatment Alternatives to Relieve Depression study. J Clin Psychiatry. 2005 Feb;66(2):159-66; quiz 147, 273-4.

Warden D, Rush AJ, Trivedi M, Ritz L, Stegman D, Wisniewski SR. Quality improvement methods as applied to a multicenter effectiveness trial--STAR*D. Contemp Clin Trials. 2005 Feb;26(1):95-112. Epub 2005 Jan 27.

Gaynes BN, Rush AJ, Trivedi M, Wisniewski SR, Balasubramani GK, Spencer DC, Petersen T, Klinkman M, Warden D, Schneider RK, Castro DB, Golden RN. A direct comparison of presenting characteristics of depressed outpatients from primary vs. specialty care settings: preliminary findings from the STAR*D clinical trial. Gen Hosp Psychiatry. 2005 Mar-Apr;27(2):87-96.

Kornstein SG, Harvey AT, Rush AJ, Wisniewski SR, Trivedi MH, Svikis DS, McKenzie ND, Bryan C, Harley R. Self-reported premenstrual exacerbation of depressive symptoms in patients seeking treatment for major depression. Psychol Med. 2005 May;35(5):683-92.

Rush AJ, Zimmerman M, Wisniewski SR, Fava M, Hollon SD, Warden D, Biggs MM, Shores-Wilson K, Shelton RC, Luther JF, Thomas B, Trivedi MH. Comorbid psychiatric disorders in depressed outpatients: demographic and clinical features. J Affect Disord. 2005 Jul;87(1):43-55.

Marcus SM, Young EA, Kerber KB, Kornstein S, Farabaugh AH, Mitchell J, Wisniewski SR, Balasubramani GK, Trivedi MH, Rush AJ. Gender differences in depression: findings from the STAR*D study. J Affect Disord. 2005 Aug;87(2-3):141-50.

Lesser IM, Leuchter AF, Trivedi MH, Davis LL, Wisniewski SR, Balasubramani GK, Petersen T, Stegman D, Rush AJ. Characteristics of insured and noninsured outpatients with depression in STAR(*)D. Psychiatr Serv. 2005 Aug;56(8):995-1004.

Novick JS, Stewart JW, Wisniewski SR, Cook IA, Manev R, Nierenberg AA, Rosenbaum JF, Shores-Wilson K, Balasubramani GK, Biggs MM, Zisook S, Rush AJ; STAR*D investigators. Clinical and demographic features of atypical depression in outpatients with major depressive disorder: preliminary findings from STAR*D. J Clin Psychiatry. 2005 Aug;66(8):1002-11.

Husain MM, Rush AJ, Sackeim HA, Wisniewski SR, McClintock SM, Craven N, Holiner J, Mitchell JR, Balasubramani GK, Hauger R. Age-related characteristics of depression: a preliminary STAR*D report. Am J Geriatr Psychiatry. 2005 Oct;13(10):852-60.

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.

Gaynes BN, Davis L, Rush AJ, Trivedi MH, Fava M, Wisniewski SR. The aims and design of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Primary Psychiatry 2005;12(2):36-41. http://www.primarypsychiatry.com/pdf/art_4845.pdf

Gilmer WS, Trivedi MH, Rush AJ, Wisniewski SR, Luther J, Howland RH, Yohanna D, Khan A, Alpert J. Factors associated with chronic depressive episodes: a preliminary report from the STAR-D project. Acta Psychiatr Scand. 2005 Dec;112(6):425-33.

Hollon SD, Shelton RC, Wisniewski S, Warden D, Biggs MM, Friedman ES, Husain M, Kupfer DJ, Nierenberg AA, Petersen TJ, Shores-Wilson K, Rush AJ. Presenting characteristics of depressed outpatients as a function of recurrence: preliminary findings from the STAR*D clinical trial. J Psychiatr Res. 2006 Feb;40(1):59-69. Epub 2005 Oct 21.

Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. Epub 2005 Sep 30.

Davis LL, Frazier E, Husain MM, Warden D, Trivedi M, Fava M, Cassano P, McGrath PJ, Balasubramani GK, Wisniewski SR, Rush AJ. Substance use disorder comorbidity in major depressive disorder: a confirmatory analysis of the STAR*D cohort. Am J Addict. 2006 Jul-Aug;15(4):278-85.

Starting date: July 2001
Last updated: September 24, 2009

Page last updated: August 23, 2015

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