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Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review


N/A
N/A
N/A
Not Enrolling
Both
Serotonin Syndrome

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Trial Information

Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review


Inclusion Criteria:



1. Male or female patients with a diagnosis of PD

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.

5. 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 Criteria:

1. Use of rasagiline for any indication other than PD

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Time Frame:

9 months

Safety Issue:

Yes

Principal Investigator

Tom Smith, MD

Investigator Role:

Study Director

Investigator Affiliation:

Teva Neuroscience, Inc.

Authority:

United States: Institutional Review Board

Study ID:

TVP-1012/PM102 CR

NCT ID:

NCT00955604

Start Date:

July 2009

Completion Date:

June 2010

Related Keywords:

  • Serotonin Syndrome
  • Parkinson's Disease
  • Serotonin Toxicity
  • Rasagiline
  • Antidepressants
  • Chart Review
  • Retrospective
  • Serotonin Syndrome
  • Malignant Carcinoid Syndrome
  • Parkinson Disease

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