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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 15, 2006

Last Updated Date

March 10, 2009

Start Date ^†

July 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00304161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease

Official Title ^†

Depression Diagnosis and Treatment in Parkinson Disease

Brief Summary

This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Depressive Disorder
Parkinson Disease

Intervention ^†

Drug: Atomoxetine
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Participants will receive atomoxetine treatment
Placebo Comparator: Participants will receive placebo treatment

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

30 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00304161

Responsible Party

Daniel Weintraub, MD, University of Pennsylvania School of Medicine

Secondary IDs ^††

DATR AK-TNGP1

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Daniel Weintraub, MD

University of Pennsylvania

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.