Status:
COMPLETED
Azilect + Antidepressant Chart Review
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Serotonin Syndrome
Eligibility:
All Genders
Brief Summary
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 med...
Eligibility Criteria
Inclusion
- 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:
- Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline).
- Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use.
- Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication.
Exclusion
- Use of rasagiline for any indication other than PD
- Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline
- Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00955604
Start Date
July 1 2009
End Date
June 1 2010
Last Update
February 6 2017
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