drugset / Trial / NCT00021528

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

NCT00021528 ↗

Phase 4 Completed 4000 enrolled National Institute of Mental Health (NIMH)
RandomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2001-07
Primary completion
—
Completion
2006-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 400 mg —
Subject Buspirone Small molecule 60 mg —
Subject Citalopram Small molecule 60 mg —
Subject Lithium Unknown 900 mg —
Subject Mirtazapine Other / unclassified 60 mg —
Subject Nortriptyline Small molecule 200 mg —
Subject Sertraline Small molecule 200 mg —
Subject T3 Unknown 50 ug —
Subject Tranylcypromine Small molecule — —
Subject Venlafaxine Small molecule 375 mg —