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OpenTrials
Completed

NCT Number: NCT00955604

Azilect + Antidepressant Chart Review

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

  • 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.

Treatment and study plan

Group R+AD Rasagiline + Antidepressant

Drug

Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days

Other names: Azilect

Group R Rasagiline

Drug

At least 2 months of rasagiline

Other names: Azilect

Group AD Anti-PD + Antidepressant

Drug

An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.

Primary outcomes

  1. 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

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Acronym: STACCATO

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2009
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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