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Study 14 of 2431 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00813800 |
Aim 1. To assess the feasibility and acceptability of varenicline among bipolar depressed smokers as determined by our recruitment and retention rates.
Hypothesis 1. The abstinence rate for bipolar depressed patients will be 50%. The retention rate for this study will be similar to the Gonzales 2006 study (approximately 75)%.
Aim 2. To estimate the 7-day point prevalence abstinence rate at week 12, with open-label varenicline and behavioral intervention among patients with bipolar depression (N=15 with major depression, N=15 with subsyndromal or depressive symptoms). The investigators primary outcome measure is 7-day point prevalence abstinence rate defined by self-report at week 12 confirmed by expired carbon monoxide levels of 10 ppm or less.
Hypothesis 2:At final visit, approximately 50% of study completers will meet the primary outcome measure. At study entry, bipolar patients with a major depressive episode, in comparison to subjects with depressive symptoms (i.e. not syndromal episode, less severe) , will have lower abstinence rates.At final visit, bipolar depressed patients who have achieved remission, defined as a Montgomery Asberg Depression Rating Scale (MADRS) <8, will have a higher rate of tobacco abstinence than depressed patients who did not achieve remission (MADRS >/= 8).
Condition | Intervention |
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Smoking Bipolar Depression |
Drug: Varenicline |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Varenicline for Smoking Cessation in Bipolar Depressed Patients: An Open-Label 12-Week Feasibility Trial |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cindy J. Stoppel | 507-284-5914 | stoppel.cynthia@mayo.edu |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Mark A. Frye, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Mark Frye, MD ) |
Study ID Numbers: | 08-003471 |
Study First Received: | December 22, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00813800 |
Health Authority: | United States: Food and Drug Administration |
Smoking Bipolar Depression |
Smoking Depression Mental Disorders |
Mood Disorders Depressive Disorder Behavioral Symptoms |
Habits |