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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Parkinson Disease
Adenocarcinoma
Basal Ganglia Diseases
Brain Diseases
Carcinoid Tumor
Carcinoma
Central Nervous System Diseases
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Movement Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Neurodegenerative Diseases
Neuroectodermal Tumors
Neuroendocrine Tumors
Parkinsonian Disorders
Antidepressive Agents
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014