Clinical trial NCT00304161: Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Official title: Depression Diagnosis and Treatment in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder
Parkinson Disease
Keywords: Depression
Parkinson's Disease
Atomoxetine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-03-17
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale
timeFrame: Week 8
Secondary outcomes:
measure: Clinical Global Impression-Improvement Scale
timeFrame: Week 8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Veterans Affairs Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Daniel Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weintraub D, Mavandadi S, Mamikonyan E, Siderowf AD, Duda JE, Hurtig HI, Colcher A, Horn SS, Nazem S, Ten Have TR, Stern MB. Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease. Neurology. 2010 Aug 3;75(5):448-55. doi: 10.1212/WNL.0b013e3181ebdd79.