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Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00048815 |
This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St. John's Wort), and placebo for the treatment of minor depression.
Condition | Intervention |
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Depression |
Drug: Citalopram Drug: St. John's Wort |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Pharmacotherapy for Minor Depression |
Estimated Enrollment: | 300 |
Study Start Date: | February 2003 |
Minor depression is highly prevalent, causes substantial morbidity and disability, presents a serious risk factor for the development of major depressive disorder, yet is under recognized and under treated. Researchers have determined that patients with minor depression frequently seek treatment from general practitioners and are often treated with prescription antidepressants. There is a need to evaluate the effectiveness of St. John's Wort in the management of minor depression. If the proposed study demonstrates the efficacy of St. John's Wort and/or citalopram, it will suggest treatment paradigms that can be tested and applied in primary care settings.
Patients who meet screening criteria enter a 2-week washout period (or, for fluoxetine, a 4-week washout period) during which no psychotropic medication is permitted. Participants are then randomly assigned to St. John's Wort, citalopram, or placebo for 12 weeks. Participants who respond to treatment by Week 12 continue to take their originally assigned double-blind medication for up to 26 weeks. At Week 12, nonresponders to placebo are crossed over to 1 of the 2 active treatments. Patients who remain nonresponders to that active treatment are crossed over to the alternative active treatment, with the investigator maintaining blind status. Participants have study visits at screening, during the washout period, at baseline, and every 2 weeks thereafter for the course of the study. At the screening visit, Week 12, and Week 20, patients undergo a complete blood count with differential and other routine laboratory tests.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Pennsylvania | |
University of Pittsburgh, Western Psychiatric Institute and Clinic | |
Pittsburgh, Pennsylvania, United States |
Principal Investigator: | Andrew A. Nierenberg |
Study ID Numbers: | R01 MH61758, R01 MH61757, R01 MH61394, DSIR AT-SO |
Study First Received: | November 8, 2002 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00048815 History of Changes |
Health Authority: | United States: Federal Government |
Neurotransmitter Agents Depression Psychotropic Drugs Depressive Disorder Citalopram Serotonin Uptake Inhibitors St. John's Wort |
Serotonin Behavioral Symptoms Mental Disorders Mood Disorders Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder Citalopram Serotonin Uptake Inhibitors |
Pharmacologic Actions Behavioral Symptoms Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |