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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00429169 |
This study will compare the effectiveness of two antidepressant medications in treating depression in people who have attempted suicide or are currently experiencing suicidal ideation.
Condition | Intervention |
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Depression |
Drug: Paroxetine CR for major depressive episode Drug: Bupropion XL for major depressive episode |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Paroxetine Versus Bupropion for Suicide Ideators or Attempters With Major Depressive Disorder |
Estimated Enrollment: | 100 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive paroxetine for 8 weeks
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Drug: Paroxetine CR for major depressive episode
Dosage will be 25 mg every day for 2 weeks, then 37.5 mg every day for 2 weeks, and then optional increase to 50 mg every day for the remainder of treatment.
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2: Active Comparator
Participants will receive bupropion for 8 weeks
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Drug: Bupropion XL for major depressive episode
Dosage will be 150 mg every day for 2 weeks, then 300 mg every day for 2 weeks, and then optional increase to 450 mg every day for the remainder of treatment.
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Major depressive disorder (MDD) is a common and serious psychiatric illness. It is among the leading causes of disability and is the psychiatric disorder that is most commonly associated with suicide. The treatment of MDD with antidepressant medication, however, remains a process based largely on trial and error. In particular, little empirical evidence exists to guide the treatment of MDD when suicide is a major factor. Selective serotonin reuptake inhibitors (SSRIs) are a type of antidepressant medication that works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. This study will compare the effectiveness of paroxetine, an SSRI antidepressant, versus bupropion, a non-SSRI antidepressant, in treating depression in people who have attempted suicide or are currently experiencing suicidal ideation.
Participants in this double-blind study will be randomly assigned to receive either paroxetine or bupropion for 8 weeks. Weekly study visits will include interviews with a psychologist, self-report scales, and medication monitoring. All participants will then be offered 4 additional months of open label treatment with their assigned medications, and study visits will occur at least monthly. If original medication assignments prove to be ineffective, participants will have the option to switch to another medication, which, in most cases, will be the other study medication. After completing the 6-month study, participants will be referred for ongoing treatment at another clinic, but will continue attending clinical follow up visits at the study site until their new care has been established.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lucia Sanchez, BA | 212-543-6216 | sanchel@pi.cpmc.columbia.edu |
Contact: Jason Turret, BA | 212-543-5834 | turretj@pi.cpmc.columbia.edu |
United States, New York | |
Columbia University/New York State Psychiatric Institute | Recruiting |
New York City, New York, United States, 10032 | |
Contact: Lucia Sanchez, BA 212-543-6216 sanchel@pi.cpmc.columbia.edu | |
Contact: Jason Turret, BA 212-543-5834 turretj@pi.cpmc.columbia.edu | |
Principal Investigator: Michael F. Grunebaum, MD |
Principal Investigator: | Michael F. Grunebaum, MD | Columbia University/New York State Psychiatric Institute |
Responsible Party: | Columbia University and New York State Psychiatric Institute ( Michael F. Grunebaum, MD ) |
Study ID Numbers: | K23 MH76049, DSIR 8KRT-AT |
Study First Received: | January 29, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00429169 |
Health Authority: | United States: Federal Government |
Major Depressive Disorder MDD |
Dopamine Depression Mental Disorders Bupropion Mood Disorders Suicide |
Depressive Disorder, Major Depressive Disorder Paroxetine Serotonin Behavioral Symptoms |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Therapeutic Uses Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |