Azilect + Antidepressant Chart Review

Serotonin Syndrome Clinical Trial

— STACCATO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955604
• Other study ID #: TVP-1012/PM102 CR
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: February 2, 2017
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2017
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Carcinoid Syndrome
• Parkinson Disease
• Serotonin Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		9 months