Drug Therapy to Treat Minor Depression
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|ClinicalTrials.gov Identifier: NCT00048815|
Recruitment Status : Completed
First Posted : November 13, 2002
Results First Posted : May 10, 2018
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Citalopram Drug: St. John's Wort Drug: Placebos||Not Applicable|
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.
Subjects participated in a 12-week double-blind randomized study comparing St. John's Wort, citalopram, and placebo. Subjects were recruited through clinical referrals and community advertising. Data were obtained at the baseline visit (just prior to randomization) and at postrandomization visits conducted at 2-week intervals for the next 12 weeks, for a modified intent-to-treat sample consisting of all 73 subjects with at least 1 post-randomization visit (evaluable sample).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pharmacotherapy for Minor Depression|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
Active Comparator: citalopram
Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
Established Selective Serotonin Reuptake Inhibitor antidepressant
Other Name: Celexa, Cipramil
Experimental: St. John's Wort
Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
Drug: St. John's Wort
Natural extract from the St. John's Wort plant.
Other Name: Hypericum
Placebo Comparator: Placebo
Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
- Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) [ Time Frame: Change from Baseline to Week 12 ]We expect that subjects with minor depression treated for 12 weeks with St. John's Wort or citalopram will have significantly greater reduction in depressive symptom severity than those treated with placebo. This will be measured by blind ratings on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) which has a total score range from 0 to 84 with 0 being not depressed at all and 84 being the most depressed. The change will be calculated by subtracting the Week 12 score from the Baseline score.
- Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment [ Time Frame: Change from Baseline to Week 12 ]We expect that subjects treated for Minor Depression for 12 weeks with either St. John's Wort or citalopram will have similar safety profiles to subjects treated with placebo, and will not differ by more than 20% in rates of adverse side effects (e.g., nausea, headache, insomnia, hypersomnia, diarrhea) from subjects treated with placebo. This was measured by the number of adverse events (physical symptoms) emerging or worsening during 12 weeks of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048815
|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, 15213|
|Principal Investigator:||Andrew A. Nierenberg, M.D.||Massachusetts General Hospital|