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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH067894 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Active Comparator | Participants will receive 40-80mgs of atomoxetine orally once daily. |
|
| Placebo | Placebo Comparator | Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | 40 to 80 mg orally once daily for 8 weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Improvement Scale | The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:
A participant scoring a 1 or 2 is considered a responder on the CGI scale. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Weintraub, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia Veterans Affairs Medical Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20679638 | Result | 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. |
| Label | URL |
|---|---|
| Manuscript | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Participants will receive 40-80mgs of atomoxetine orally once daily. |
| FG001 | Placebo | Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Participants will receive atomoxetine treatment |
| BG001 | Placebo | Participants will receive placebo treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of improved participants | Week 8 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Participants will receive 40-80mgs of atomoxetine orally once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
First, the sample size was relatively small. Second, the diagnostic criteria for depression which are typically used in clinical trials were not used as an inclusion criterion. Third, antidepressant use at baseline was common in our population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Weintraub | University of Pennsylvania | 215-349-8207 | daniel.weintraub@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D010300 | Parkinson Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 40 to 80 mg orally once daily for 8 weeks |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. |
|
|
| Secondary | Clinical Global Impression-Improvement Scale | The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:
A participant scoring a 1 or 2 is considered a responder on the CGI scale. | Posted | Number | percentage of responders | Week 8 |
|
|
|
| 2 |
| 28 |
| 7 |
| 28 |
| EG001 | Placebo | Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. | 2 | 27 | 6 | 27 |
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
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| Urosepsis | Renal and urinary disorders | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |