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To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group R+AD | Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days |
| |
| Group R | At least 2 months of rasagiline |
| |
| Group AD | At least 2 months of Anti-PD and Rasagiline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group R+AD Rasagiline + Antidepressant | Drug | Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of serotonin toxicity, as determined by the Adjudication Committee will be calculated for each Group. The primary comparison will be Group R+AD vs. Group R and vs. Group AD | 9 months |
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Inclusion Criteria:
Male or female patients with a diagnosis of PD
Rasagiline treatment as mono- or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono- or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period
Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required
Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation.
In addition to the above criteria, each group has specific inclusion criteria stated below:
Exclusion Criteria:
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Male or female patients with a diagnosis of PD:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Smith, MD | Teva Neuroscience, Inc. | Study Director |
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| ID | Term |
|---|---|
| D020230 | Serotonin Syndrome |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| C031967 | rasagiline |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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| Group R Rasagiline | Drug | At least 2 months of rasagiline |
|
|
| Group AD Anti-PD + Antidepressant | Drug | An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication. |
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020164 | Chemical Actions and Uses |