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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: | NCT00304161 |
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder Parkinson Disease |
Drug: Atomoxetine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Depression Diagnosis and Treatment in Parkinson Disease |
Estimated Enrollment: | 80 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive atomoxetine treatment
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Drug: Atomoxetine
40 to 80 mg qd for 8 weeks
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2: Placebo Comparator
Participants will receive placebo treatment
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Drug: Placebo
40 to 80 mg qd for 8 weeks
|
Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.
Ages Eligible for Study: | 30 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel Weintraub, MD | 215-349-8207 | weintrau@mail.med.upenn.edu |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Daniel Weintraub, MD 215-349-8207 weintrau@mail.med.upenn.edu | |
Principal Investigator: Daniel Weintraub, MD | |
Philadelphia Veterans Affairs Medical Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Daniel Weintraub, MD 215-349-8207 weintrau@mail.med.upenn.edu | |
Principal Investigator: Daniel Weintraub, MD |
Principal Investigator: | Daniel Weintraub, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania School of Medicine ( Daniel Weintraub, MD ) |
Study ID Numbers: | K23 MH67894, DATR AK-TNGP1 |
Study First Received: | March 15, 2006 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00304161 |
Health Authority: | United States: Federal Government |
Depression Parkinson's Disease Atomoxetine |
Depression Ganglion Cysts Basal Ganglia Diseases Atomoxetine Central Nervous System Diseases Depressive Disorder Brain Diseases |
Neurodegenerative Diseases Behavioral Symptoms Parkinson Disease Mental Disorders Movement Disorders Mood Disorders Parkinsonian Disorders |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |