Azilect + Antidepressant Chart Review (STACCATO)

February 2, 2017 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group R+AD
Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days
Drug: Group R+AD Rasagiline + Antidepressant
Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days
Other Names:
  • Azilect
Group R
At least 2 months of rasagiline
Drug: Group R Rasagiline
At least 2 months of rasagiline
Other Names:
  • Azilect
Group AD
At least 2 months of Anti-PD and Rasagiline
Drug: Group AD Anti-PD + Antidepressant
An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Director: Tom Smith, MD, Teva Neuroscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVP-1012/PM102 CR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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