Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
citalopram
BuproprionSR
buspirone
Lithium
mirtazapine
nortriptyline
sertraline
tranylcypromine
VenlafaxineXR
Cognitive Therapy
T3 (Triiodothyronine)
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Sequential Treatment, Major Depression, Treatment Resistant Depression
Eligibility Criteria
- Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)
Sites / Locations
- Birmingham VA Medical Center
- Tuscaloosa VA Mental Health Clinic - Veterans Only
- Tuscaloosa VA Primary Care Center
- Psychiatric Centers at San Diego
- Harbor UCLA Family Health Care Center
- UCLA General Outpatient Psychiatry Clinic
- UCLA Internal Medicine Clinic
- UCSD Outpatient Psychiatric Services
- Veterans Affairs Medical Center/FIRM Primary Care Clinic
- Harbor UCLA Medical Center
- Northwestern Outpatient Treatment Care Center
- University of Illinois at Chicago Clinic
- Evanston Outpatient Clinic
- COMCARE of Sedgwick County
- Psychiatric Outpatient Clinic
- Swampscott Family Doctors
- Internal Medicine Associates
- MGH/Charlestown Clinic
- MGH/Salem Professional
- General Psychiatric Ambulatory Clinic
- Briarwood Family Practice Clinic
- LIJ/Zucker Hillside Adult Ambulatory Care Center
- LIJ North Shore Medical Group
- UNC Chapel Hill General Medicine Clinic
- UNC Chapel Hill Adult Diagnostic & Treatment Clinic
- UNC Chapel Hill Family Practice Clinic
- Springer Family Medicine
- Laureate Psychiatric Clinic & Hospital
- Warren Clinic
- Diversified Human Services Clinic
- Latterman Family Health Center
- Bellefield Clinic of WPIC
- AMPN Corkery, Heise & Dainesi
- Psychiatric Consultants, P.C.
- Vanderbilt University Medical Center-Mental Health Center
- Vine Hill Community Clinic
- Centerstone/Luton Mental Health Services
- The Holiner Psychiatric Group
- UT Southwestern Family Medicine Clinic
- MCV Primary Care Clinic
- MCV Family Counseling
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00021528
First Posted
July 20, 2001
Last Updated
September 24, 2009
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00021528
Brief Title
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
Official Title
Sequenced Treatment Alternatives to Relieve Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Sequential Treatment, Major Depression, Treatment Resistant Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
citalopram
Intervention Type
Drug
Intervention Name(s)
BuproprionSR
Intervention Type
Drug
Intervention Name(s)
buspirone
Intervention Type
Drug
Intervention Name(s)
Lithium
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Intervention Type
Drug
Intervention Name(s)
nortriptyline
Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Type
Drug
Intervention Name(s)
tranylcypromine
Intervention Type
Drug
Intervention Name(s)
VenlafaxineXR
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Intervention Type
Drug
Intervention Name(s)
T3 (Triiodothyronine)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. John Rush, MD
Organizational Affiliation
University of Texas Southwestern Medical Center Department of Psychiatry
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham VA Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35223
Country
United States
Facility Name
Tuscaloosa VA Mental Health Clinic - Veterans Only
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Tuscaloosa VA Primary Care Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Facility Name
Psychiatric Centers at San Diego
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Harbor UCLA Family Health Care Center
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
UCLA General Outpatient Psychiatry Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Internal Medicine Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCSD Outpatient Psychiatric Services
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Veterans Affairs Medical Center/FIRM Primary Care Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Northwestern Outpatient Treatment Care Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Evanston Outpatient Clinic
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
COMCARE of Sedgwick County
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Psychiatric Outpatient Clinic
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-2878
Country
United States
Facility Name
Swampscott Family Doctors
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
01907
Country
United States
Facility Name
Internal Medicine Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MGH/Charlestown Clinic
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
MGH/Salem Professional
City
Salem
State/Province
Massachusetts
ZIP/Postal Code
01970
Country
United States
Facility Name
General Psychiatric Ambulatory Clinic
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-0722
Country
United States
Facility Name
Briarwood Family Practice Clinic
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0708
Country
United States
Facility Name
LIJ/Zucker Hillside Adult Ambulatory Care Center
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
LIJ North Shore Medical Group
City
Lake Success
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
UNC Chapel Hill General Medicine Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7110
Country
United States
Facility Name
UNC Chapel Hill Adult Diagnostic & Treatment Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7160
Country
United States
Facility Name
UNC Chapel Hill Family Practice Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27955
Country
United States
Facility Name
Springer Family Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Laureate Psychiatric Clinic & Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Warren Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Diversified Human Services Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15062
Country
United States
Facility Name
Latterman Family Health Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
Facility Name
Bellefield Clinic of WPIC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
AMPN Corkery, Heise & Dainesi
City
Upper St. Clair
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
Facility Name
Psychiatric Consultants, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center-Mental Health Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vine Hill Community Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Centerstone/Luton Mental Health Services
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37217
Country
United States
Facility Name
The Holiner Psychiatric Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Southwestern Family Medicine Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MCV Primary Care Clinic
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
MCV Family Counseling
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0268
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14677083
Citation
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Results Reference
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Citation
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. doi: 10.1016/s0006-3223(01)01223-9.
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Links:
URL
http://www.star-d.org
Description
Click here for more information about this study
URL
http://www.nimh.nih.gov/health/topics/depression/index.shtml
Description
More information on depression
Learn more about this trial
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
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