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

NCT00955604 COMPLETED

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.

Details

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Status	COMPLETED
Enrolment	1500
Start date	2009-07
Completion	2010-06

Conditions

• Serotonin Syndrome

Interventions

• Group R+AD Rasagiline + Antidepressant
• Group R Rasagiline
• Group AD Anti-PD + Antidepressant

Primary outcomes

• 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