Depressive Disorder, Parkinson Disease
Conditions
Keywords
Depression, Parkinson's Disease, Atomoxetine
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.
Interventions
DRUGAtomoxetine
40 to 80 mg orally once daily for 8 weeks
DRUGPlacebo
40 to 80 mg orally once daily for 8 weeks
Sponsors
National Institute of Mental Health (NIMH)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from The Parkinson's Disease and Movement Disorders Center at Pennsylvania Hospital and the Parkinson's Disease Research, Education, and Clinical Center at the Philadelphia Veterans Affairs Medical Center between 2004-2009.
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine Participants will receive atomoxetine treatment | 28 |
| Placebo Participants will receive placebo treatment | 27 |
| Total | 55 |
Baseline characteristics
| Characteristic | Placebo | Atomoxetine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 14 Participants | 25 Participants |
| Age, Continuous | 64.9 years STANDARD_DEVIATION 11.5 | 63.8 years STANDARD_DEVIATION 9.5 | 64.3 years STANDARD_DEVIATION 10.5 |
| Gender Female | 11 Participants | 8 Participants | 19 Participants |
| Gender Male | 16 Participants | 20 Participants | 36 Participants |
| Region of Enrollment United States | 27 participants | 28 participants | 55 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 28 | 6 / 27 |
| serious Total, serious adverse events | 2 / 28 | 2 / 27 |
Outcome results
Primary
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.
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atomoxetine | Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale | 22.7 percentage of improved participants |
| Placebo | Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale | 9.5 percentage of improved participants |
Secondary
Clinical Global Impression-Improvement Scale
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.
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atomoxetine | Clinical Global Impression-Improvement Scale | 45.5 percentage of responders |
| Placebo | Clinical Global Impression-Improvement Scale | 33.3 percentage of responders |