Conditions: Depressive Disorder Parkinson Disease
Keywords: Depression Parkinson's Disease Atomoxetine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

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.

Arms:
arm 1: Participants will receive 40-80mgs of atomoxetine orally once daily. arm 2: Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 40 to 80 mg orally once daily for 8 weeks intervention 2: 40 to 80 mg orally once daily for 8 weeks

Protocol document: