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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by (Responsible Party): | Daniel Weintraub, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00304161 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Depression Diagnosis and Treatment in Parkinson Disease |
| Enrollment: | 55 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive atomoxetine treatment
|
Drug: Atomoxetine
40 to 80 mg qd for 8 weeks
|
|
Placebo Comparator: 2
Participants will receive placebo treatment
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Philadelphia Veterans Affairs Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Daniel Weintraub, MD | University of Pennsylvania |
More Information
| Responsible Party: | Daniel Weintraub, Associate Professor of Psychiatry and Neurology, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00304161 History of Changes |
| Other Study ID Numbers: | K23 MH067894, K23MH067894, DATR AK-TNGP1 |
| Study First Received: | March 15, 2006 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Federal Government |
|
Depression Parkinson's Disease Atomoxetine |
|
Depression Depressive Disorder Parkinson Disease Behavioral Symptoms Mood Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
Antidepressive Agents Atomoxetine Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |