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

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Parkinson Disease; Depressive Disorder

Treatments: Drug: Atomoxetine; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00304161

K23MH067894 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups, including a placebo group

Atomoxetine

Active Comparator group

Description:

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

Treatment:

Drug: Atomoxetine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo