Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1500 participants
OBSERVATIONAL
2009-07-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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+AD Rasagiline + Antidepressant
Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days
Group R
At least 2 months of rasagiline
Group R Rasagiline
At least 2 months of rasagiline
Group AD
At least 2 months of Anti-PD and Rasagiline
Group AD Anti-PD + Antidepressant
An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.
Interventions
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Group R+AD Rasagiline + Antidepressant
Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days
Group R Rasagiline
At least 2 months of rasagiline
Group AD Anti-PD + Antidepressant
An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. 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.
* 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 Criteria
2. Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline
3. Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period.
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Smith, MD
Role: STUDY_DIRECTOR
Teva Neuroscience, Inc.
Other Identifiers
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TVP-1012/PM102 CR
Identifier Type: -
Identifier Source: org_study_id
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