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Sponsored by: |
University of Cincinnati |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00585585 |
The purpose of this study is to determine a dose of the investigational drug betahistine that is both well tolerated and potentially effective in treating the symptoms of atypical depression. Atypical depression is characterized by the ability of the person's mood to improve temporarily in response to positive events, as well as features such as increased appetite, increased sleep and severe fatigue.
Condition | Intervention | Phase |
---|---|---|
Major Depression, Atypical Features |
Drug: Betahistine dihydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features |
Estimated Enrollment: | 5 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Betahistine dihydrochloride
oral, 50 mg/day - 300 mg/day
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erik B. Nelson, MD | 513-558-5115 | erik.nelson@uc.edu |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45267-0559 | |
Contact: Erik B Nelson, MD 513-558-5115 erik.nelson@uc.edu | |
Contact: Christa Lloyd, BA 513-558-3249 christa.lloyd@uc.edu |
Responsible Party: | University of Cincinnati ( Erik B. Nelson, MD / Assistant Professor ) |
Study ID Numbers: | Nelson #1 |
Study First Received: | December 28, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585585 |
Health Authority: | United States: Food and Drug Administration |
Depression Mental Disorders Mood Disorders Histamine phosphate Betahistine |
Depressive Disorder, Major Depressive Disorder Histamine Behavioral Symptoms |
Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Histamine Agonists Therapeutic Uses |
Physiological Effects of Drugs Histamine Agents Cardiovascular Agents Pharmacologic Actions |