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Azilect + Antidepressant Chart Review (STACCATO)

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00955604
First received: August 6, 2009
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Serotonin Syndrome
 Drug: Group R+AD Rasagiline + Antidepressant
Drug: Group R Rasagiline
Drug: Group AD Anti-PD + Antidepressant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Azilect
Group R
At least 2 months of rasagiline
 Drug: Group R Rasagiline
At least 2 months of rasagiline
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955604

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Tom Smith, MD Teva Neuroscience, Inc.
  More Information

No publications provided

Responsible Party: Julie Mathena, Clinical Trial Manager, Teva Neuroscience, Inc.
ClinicalTrials.gov Identifier: NCT00955604     History of Changes
Other Study ID Numbers: TVP-1012/PM102 CR
Study First Received: August 6, 2009
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
Parkinson's Disease
Serotonin Toxicity
Rasagiline
 Antidepressants
Chart Review
Retrospective

Additional relevant MeSH terms:
Serotonin Syndrome
Malignant Carcinoid Syndrome
Parkinson Disease
Drug Toxicity
Poisoning
Substance-Related Disorders
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antidepressive Agents
Rasagiline
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Monoamine Oxidase Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013