Clinical trial NCT00955604: Azilect + Antidepressant Chart Review
Official title: Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serotonin Syndrome
Keywords: Parkinson's Disease
Serotonin Toxicity
Rasagiline
Antidepressants
Chart Review
Retrospective
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-10
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients with a diagnosis of PD:

* who received rasagiline at any dose, as mono- or adjunct therapy for PD, with concomitant antidepressant medication, OR
* who received rasagiline at any dose, as mono- or adjunct therapy for PD, without concomitant antidepressant medication, OR
* who received antidepressant medication and any other dopaminergic anti-PD therapy besides rasagiline or selegiline including dopaminergic agents, anticholinergics, amantadine, deep brain stimulation (DBS), pallidotomy, etc.

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 medications and compared to PD patients receiving antidepressants, but not rasagiline.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Tom Smith, MD
role: STUDY_DIRECTOR
References: