Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

This study has been completed.
Information provided by:
National Institute of Mental Health (NIMH) Identifier:
First received: July 20, 2001
Last updated: September 24, 2009
Last verified: September 2006

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

Condition Intervention Phase
Drug: citalopram
Drug: BuproprionSR
Drug: buspirone
Drug: Lithium
Drug: mirtazapine
Drug: nortriptyline
Drug: sertraline
Drug: tranylcypromine
Drug: VenlafaxineXR
Behavioral: Cognitive Therapy
Drug: T3 (Triiodothyronine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequenced Treatment Alternatives to Relieve Depression

Resource links provided by NLM:

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 4000
Study Start Date: July 2001
Estimated Study Completion Date: September 2006
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Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00021528

  Show 41 Study Locations
Sponsors and Collaborators
Study Director: A. John Rush, MD University of Texas Southwestern Medical Center Department of Psychiatry
  More Information

Additional Information:
Gilmer WS, Kemp DE. STAR*D: What Have We Learned Thus Far? International Drug Therapy Newsletter 41:75-82, 2006.
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.
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.

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00021528     History of Changes
Other Study ID Numbers: N01 MH90003, DSIR AT
Study First Received: July 20, 2001
Last Updated: September 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Sequential Treatment
Major Depression
Treatment Resistant Depression

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Anxiety Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on July 05, 2015