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Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Sequenced Treatment Alternatives to Relieve Depression (STAR*D) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Clinical research trials and Sequenced Treatment Alternatives to Relieve Depression (STAR*D) health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Sequenced Treatment Alternatives to Relieve Depression (STAR*D). Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial. Human subjects frequently get the finest healthcare available for their Sequenced Treatment Alternatives to Relieve Depression (STAR*D) condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Sequenced Treatment Alternatives to Relieve Depression (STAR*D)  Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
For Condition: Depression
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: - Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)
Total Enrollment: 4000
Location and Contact Information:
Overall Study Official:
A.Rush, Study Director, University of Texas Southwestern Medical Center Department of Psychiatry
Warren Clinic
Tulsa, Oklahoma, 74136
United States
Latterman Family Health Center
Pittsburgh, Pennsylvania, 15132
United States
MCV Family Counseling
Richmond, Virginia, 23298-0268
United States
UNC Chapel Hill Adult Diagnostic & Treatment Clinic
Chapel Hill, North Carolina, 27599-7160
United States
UT Southwestern Family Medicine Clinic
Dallas, Texas, 75390
United States
Tuscaloosa VA Mental Health Clinic - Veterans Only
Tuscallosa, Alabama, 35404
United States
AMPN Corkery, Heise & Dainesi
Upper St. Clair, Pennsylvania, 15317
United States
Harbor UCLA Family Health Care Center
Harbor City, California, 90710
United States
UNC Chapel Hill Family Practice Clinic
Chapel Hill, North Carolina, 27955
United States
UCSD Outpatient Psychiatric Services
San Diego, California, 92103
United States
The Holiner Psychiatric Group
Dallas, Texas, 75230
United States
UNC Chapel Hill General Medicine Clinic
Chapel Hill, North Carolina, 27599-7110
United States
Vanderbilt University Medical Center-Mental Health Center
Nashville, Tennessee, 37212
United States
UCLA General Outpatient Psychiatry Clinic
Los Angeles, California, 90024
United States
Springer Family Medicine
Tulsa, Oklahoma, 74135
United States
Tuscaloosa VA Primary Care Center
Tuscallosa, Alabama, 35404
United States
Birmingham VA Medical Center
Birmingham, Alabama, 35223
United States
LIJ North Shore Medical Group
Lake Success, New York, 11040
United States
Psychiatric Consultants, P.C.
Nashville, Tennessee, 37203
United States
MGH/Charlestown Clinic
Charlestown, Massachusetts, 02129
United States
Psychiatric Centers at San Diego
Chula Vista, California, 91910
United States
LIJ/Zucker Hillside Adult Ambulatory Care Center
Glen Oaks, New York, 11004
United States
Centerstone/Luton Mental Health Services
Nashville, Tennessee, 37217
United States
Diversified Human Services Clinic
Pittsburgh, Pennsylvania, 15062
United States
Laureate Psychiatric Clinic & Hospital
Tulsa, Oklahoma, 74136
United States
Swampscott Family Doctors
Boston, Massachusetts, 01907
United States
Bellefield Clinic of WPIC
Pittsburgh, Pennsylvania, 15213
United States
Harbor UCLA Medical Center
Torrance, California, 90509
United States
General Psychiatric Ambulatory Clinic
Ann Arbor, Michigan, 48105-0722
United States
Evanston Outpatient Clinic
Evanston, Illinois, 60201
United States
University of Illinois at Chicago Clinic
Chicago, Illinois, 60612
United States
MGH/Salem Professional
Salem, Massachusetts, 01970
United States
Veterans Affairs Medical Center/FIRM Primary Care Clinic
San Diego, California, 92161
United States
Vine Hill Community Clinic
Nashville, Tennessee, 37212
United States
Internal Medicine Associates
Boston, Massachusetts, 02114
United States
Psychiatric Outpatient Clinic
Wichita, Kansas, 67214-2878
United States
MCV Primary Care Clinic
Richmond, Virginia, 23220
United States
UCLA Internal Medicine Clinic
Los Angeles, California, 90024
United States
Briarwood Family Practice Clinic
Ann Arbor, Michigan, 48109-0708
United States
Northwestern Outpatient Treatment Care Center
Chicago, Illinois, 60611
United States
COMCARE of Sedgwick County
Wichita, Kansas, 67203
United States
Additional Information:
Study ID Numbers: N01MH90003;
Study Start Date: July 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021528
Other Depression Studies:
1. Cognitive and Drug Therapy for Drug-Resistant Depression
2. Clinical Trial of Memantine for Major Depression
3. Medication Treatment for Depression in Nursing Home Residents
4. Bone Loss in Premenopausal Women with Depression
5. Electroacupuncture for Major Depression
Related Studies:
Other Depression Clinical Trials
Other Kansas Clinical Trials
Other Wichita Clinical Trials
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
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