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Drug Therapy to Treat Minor Depression Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Drug Therapy to Treat Minor Depression conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Drug Therapy to Treat Minor Depression Clinical research trials and Drug Therapy to Treat Minor Depression medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Drug Therapy to Treat Minor Depression. Drug Therapy to Treat Minor Depression Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Drug Therapy to Treat Minor Depression clinical trial. Participants frequently obtain the most expert healthcare available for their Drug Therapy to Treat Minor Depression condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Drug Therapy to Treat Minor Depression  Drug Therapy to Treat Minor Depression
Drug Therapy to Treat Minor Depression
For Condition: Depression
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) , National Center for Complementary and Alternative Medicine (NCCAM),Office of Dietary Supplements (ODS)
Synopsis: The purpose of this study is to assess the effectiveness and safety of St. John's Wort and citalopram (Celexa), each compared to a placebo, for the treatment of minor depression.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Minor Depression symptoms for at least 6 months - Endorse one of the DSM-IV "A" criteria for MDD and at least one other symptom of MDD or endorse both of the "A" criteria for MDD - Global Assessment of Functioning (GAF) score < 70 - Short form health survey (SF-36) social functioning score <= 75% or an emotional role functioning score <= 67% - HAM-D-17 score 10-17, inclusive - Minor depression symptoms for at least 6 months Exclusion Criteria: - Major depressive disorder (MDD) or dysthymia within the past year or in partial remission of MDD - At least a 12-week course of either citalopram at a minimum or 40 mg/day or St. John's Wort at a minimum of 900 mg/day during the current episode of depression - Previous intolerance to either citalopram or St. John's Wort or history of nonresponse to either citalopram at a minimum of 40 mg/day or St. John's Wort at a minimum of 900 mg/day for at least 12 weeks - Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease - Uncontrolled seizure disorder - The following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last year or patients with a positive urine drug screen; schizophrenia; delusional disorder; psychotic disorders not elsewhere classified; bipolar disorder; bereavement; adjustment disorder; antisocial personality disorder; panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD). Patients may have a lifetime diagnosis of an anxiety disorder as long as it is not current. - Mood-congruent or mood-incongruent psychotic features - Psychotropic drugs - Hypothyroidism - Investigational psychotropic drugs within the last year - Positive toxicology screen - Medications metabolized by the CYP3A4 system, where induction of this system poses a risk to the medical stability of the patient - Pregnancy or refusal to use a medically accepted method of contraception - Serious suicide or homicide risk - Psychotherapy beginning less than 3 months ago
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
AndrewNierenberg, Principal Investigator,
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts,
United States
Recruiting Alana Burns 617-724-3222
University of Pittsburgh, Western Psychiatric Institute and Clinic *Recruiting*
Pittsburgh, Pennsylvania,
United States
Recruiting Michael Lightfoot 412-624-5035
Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California,
United States
Recruiting Justin Henderson 310-423-0744
Additional Information:
Study ID Numbers: 61758-01A2; 61757-01A2,61394-01A2
Study Start Date: February 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048815
Other Depression Studies:
1. Examination of a Soy-Based Supplement for Major Depression
2. Middle School to High School Transition Project
3. Treatment for Depressed Preadolescent Girls
4. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
5. Clinical trials of two non-drug treatments for chronic depression
Related Studies:
Other Depression Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Drug Therapy to Treat Minor Depression
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