Azilect + Antidepressant Chart Review

NCT00955604 | Completed

• 1 other identifier: TVP-1012/PM102 CR
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Serotonin Syndrome

Keywords

Parkinson's Disease; Serotonin Toxicity; Rasagiline; Antidepressants; Chart Review; Retrospective

Outcome Measures

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

  9 months

Study Arms (3)

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

Group R

At least 2 months of rasagiline

Drug: Group R Rasagiline

Group AD

At least 2 months of Anti-PD and Rasagiline

Drug: Group AD Anti-PD + Antidepressant

Interventions

Group R+AD Rasagiline + Antidepressant DRUG

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

Also known as: Azilect

Group R+AD

Group R Rasagiline DRUG

At least 2 months of rasagiline

Also known as: Azilect

Group R

Group AD Anti-PD + Antidepressant DRUG

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

Group AD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Serotonin Syndrome; Parkinson Disease

Interventions

Antidepressive Agents; rasagiline

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Tom Smith, MD

  Teva Neuroscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 10, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 6, 2017

Record last verified: 2017-02