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

Phase 4

Completed

• Conditions: Depressive Disorder; Parkinson Disease
• Interventions: Drug: Atomoxetine; Drug: Placebo

• Registration Number: NCT00304161
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2012-06-12
• Results First Submitted QC: 2015-03-10
• Results First Posted: 2015-03-13
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atomoxetine	Atomoxetine	Participants will receive 40-80mgs of atomoxetine orally once daily.
Placebo	Placebo	Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

Primary Outcome Measures

Name	Time	Method
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale	Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement Scale	Week 8	The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: 1. = Very much improved; 2. = Much improved; 3. = Minimally improved; 4. = No change; 5. = Minimally worse; 6. = Much worse; 7. = Very much worse; A participant scoring a 1 or 2 is considered a responder on the CGI scale.

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Philadelphia Veterans Affairs Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States