Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Depression Parkinson's Disease

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Change in score on the IDS scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Score on the CGI-I scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]

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
1: Active Comparator Participants will receive atomoxetine treatment	Drug: Atomoxetine 40 to 80 mg qd for 8 weeks
2: Placebo Comparator Participants will receive placebo treatment	Drug: Placebo 40 to 80 mg qd for 8 weeks

Detailed Description:

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

Criteria

Inclusion Criteria:

Diagnosis of idiopathic Parkinson's disease
IDS score greater than 21
Mini-Mental State Examination (MMSE) score greater than 15

Exclusion Criteria:

Recent deep brain stimulation
Currently participating in an antidepressant trial at a less than adequate dose and duration
Severe depression or depression with suicide ideation
History of liver toxicity
Unstable medical disease or comorbid psychiatric disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304161

Contacts

Contact: Daniel Weintraub, MD

215-349-8207

weintrau@mail.med.upenn.edu

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Daniel Weintraub, MD

University of Pennsylvania

More Information

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

Keywords provided by National Institute of Mental Health (NIMH):

Depression
Parkinson's Disease
Atomoxetine

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009