Clinical trial NCT00021528: Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
Official title: Sequenced Treatment Alternatives to Relieve Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Sequential Treatment
Major Depression
Treatment Resistant Depression
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2001-07-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Mental Health Clinic - Veterans Only
state: Alabama
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Primary Care Center
state: Alabama
city: Chula Vista
country: United States
facility: Psychiatric Centers at San Diego
state: California
city: Harbor City
country: United States
facility: Harbor UCLA Family Health Care Center
state: California
city: Los Angeles
country: United States
facility: UCLA General Outpatient Psychiatry Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Internal Medicine Clinic
state: California
city: San Diego
country: United States
facility: UCSD Outpatient Psychiatric Services
state: California
city: San Diego
country: United States
facility: Veterans Affairs Medical Center/FIRM Primary Care Clinic
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern Outpatient Treatment Care Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago Clinic
state: Illinois
city: Evanston
country: United States
facility: Evanston Outpatient Clinic
state: Illinois
city: Wichita
country: United States
facility: COMCARE of Sedgwick County
state: Kansas
city: Wichita
country: United States
facility: Psychiatric Outpatient Clinic
state: Kansas
city: Boston
country: United States
facility: Swampscott Family Doctors
state: Massachusetts
city: Boston
country: United States
facility: Internal Medicine Associates
state: Massachusetts
city: Charlestown
country: United States
facility: MGH/Charlestown Clinic
state: Massachusetts
city: Salem
country: United States
facility: MGH/Salem Professional
state: Massachusetts
city: Ann Arbor
country: United States
facility: General Psychiatric Ambulatory Clinic
state: Michigan
city: Ann Arbor
country: United States
facility: Briarwood Family Practice Clinic
state: Michigan
city: Glen Oaks
country: United States
facility: LIJ/Zucker Hillside Adult Ambulatory Care Center
state: New York
city: Lake Success
country: United States
facility: LIJ North Shore Medical Group
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill General Medicine Clinic
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Adult Diagnostic & Treatment Clinic
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Family Practice Clinic
state: North Carolina
city: Tulsa
country: United States
facility: Springer Family Medicine
state: Oklahoma
city: Tulsa
country: United States
facility: Laureate Psychiatric Clinic & Hospital
state: Oklahoma
city: Tulsa
country: United States
facility: Warren Clinic
state: Oklahoma
city: Pittsburgh
country: United States
facility: Diversified Human Services Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Latterman Family Health Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Bellefield Clinic of WPIC
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: AMPN Corkery, Heise & Dainesi
state: Pennsylvania
city: Nashville
country: United States
facility: Psychiatric Consultants, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center-Mental Health Center
state: Tennessee
city: Nashville
country: United States
facility: Vine Hill Community Clinic
state: Tennessee
city: Nashville
country: United States
facility: Centerstone/Luton Mental Health Services
state: Tennessee
city: Dallas
country: United States
facility: The Holiner Psychiatric Group
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Family Medicine Clinic
state: Texas
city: Richmond
country: United States
facility: MCV Primary Care Clinic
state: Virginia
city: Richmond
country: United States
facility: MCV Family Counseling
state: Virginia
Study officials:
affiliation: University of Texas Southwestern Medical Center Department of Psychiatry
name: A. John Rush, MD
role: STUDY_DIRECTOR
References:
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