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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.
Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden.
Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.
A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nortriptyline | Experimental | drug |
|
| paroxetine | Experimental | drug |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paroxetine | Drug | Paroxetine CR 12.5 - 25 mg q hs |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale | total score on HDRS (0-54 higher score is worse) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Responders | Percent of patients who had a 50% decrease in total HDRS at 8 weeks | 8 weeks |
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inclusion criteria:
exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Menza, M.D. | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19092112 | Result | Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17. | |
| 20808132 | Derived | Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Friedman J. Depression in Parkinson's disease: symptom improvement and residual symptoms after acute pharmacologic management. Am J Geriatr Psychiatry. 2011 Mar;19(3):222-9. doi: 10.1097/JGP.0b013e3181e448f7. |
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Patients who met inclusion and not exclusion criteria were enrolled.
Patients were recruited between 10/2003 and 7/2007, from the RWJMS movement disorder clinic and advertising to local support groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nortriptyline | Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg. |
| FG001 | Paroxetine | Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. . |
| FG002 | Placebo | Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nortriptyline | Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg. |
| BG001 | Paroxetine |
| 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 | Hamilton Depression Scale | total score on HDRS (0-54 higher score is worse) | intent to treat - total patients in the arm | Posted | Least Squares Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
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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 | Nortriptyline |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fainting | Nervous system disorders | Non-systematic Assessment | patient was hospitalized for fainting |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
This was only an eight week trial with relatively few participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Menza, MD | UMDNJ - RWJMS | 732-235-4440 | menza@umdnj.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003986 | Dibenzocycloheptenes |
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| Nortriptyline | Drug | nortriptyline 25 - 75 mg q hs |
|
|
| placebo | Other | matching placebo |
|
| 20463113 | Derived | Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Troster A. The impact of antidepressant treatment on cognitive functioning in depressed patients with Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2010 Spring;22(2):188-95. doi: 10.1176/jnp.2010.22.2.188. |
Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg. |
| BG002 | Placebo | Placebo was started at 1 pill and could be increased up to three pills. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Percent Responders | Percent of patients who had a 50% decrease in total HDRS at 8 weeks | intent to treat | Posted | Number | percent of patients who were responders | 8 weeks |
|
|
|
|
| 0 |
| 17 |
| 17 |
| 17 |
| EG001 | Paroxetine | 1 | 18 | 7 | 18 |
| EG002 | Placebo | 2 | 17 | 11 | 17 |
|
| muscle rigidity | Nervous system disorders | Non-systematic Assessment | increased parkinsonism |
|
| delirium | Nervous system disorders | Non-systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| insomnia | Nervous system disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| orthostatic hypotension | Cardiac disorders | Systematic Assessment |
|
| dizziness | Cardiac disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001567 |
| Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |