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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Depressive Disorder Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Atomoxetine

Participants will receive 40-80mgs of atomoxetine orally once daily.

Group Type ACTIVE_COMPARATOR

Atomoxetine

Intervention Type DRUG

40 to 80 mg orally once daily for 8 weeks

Placebo

Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

40 to 80 mg orally once daily for 8 weeks

Interventions

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Atomoxetine

40 to 80 mg orally once daily for 8 weeks

Intervention Type DRUG

Placebo

40 to 80 mg orally once daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Straterra

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No