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

Study Overview
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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.

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.

Official Title
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Depression Diagnosis and Treatment in Parkinson Disease

Conditions
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Depressive Disorder, Parkinson Disease

Intervention / Treatment
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* Drug: Atomoxetine
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atomoxetine<br>Participants will receive 40-80mgs of atomoxetine orally once daily. | Drug: Atomoxetine<br>* 40 to 80 mg orally once daily for 8 weeks<br>* Other names: Straterra;|
| Placebo Comparator: Placebo<br>Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. | Drug: Placebo<br>* 40 to 80 mg orally once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale | The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Improvement Scale | The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: = Very much improved = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse A participant scoring a 1 or 2 is considered a responder on the CGI scale. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Parkinson's Disease, Atomoxetine