Serotonin SyndromeSTACCATONCT00955604
Azilect + Antidepressant Chart Review
An observational study of Serotonin Syndrome, run by Teva Branded Pharmaceutical Products R&D, Inc..
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Serotonin Syndrome
- What is being tested?
- Group R+AD Rasagiline + Antidepressant, Group R Rasagiline and Group AD Anti-PD + Antidepressant
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- Group R+AD Rasagiline + Antidepressant, Group R Rasagiline, Group AD Anti-PD + Antidepressant
- Keywords
- Parkinson's Disease, Serotonin Toxicity, Rasagiline, Antidepressants, Chart Review, Retrospective
- Medical subject headings
- Serotonin Syndrome, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group R+AD Rasagiline + AntidepressantDrug
Also called Azilect
Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days
Group R RasagilineDrug
Also called Azilect
At least 2 months of rasagiline
Group AD Anti-PD + AntidepressantDrug
An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.
| Study group | Role | What they receive |
|---|---|---|
| Group R+AD | Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days Receives: Drug: Group R+AD Rasagiline + Antidepressant | |
| Group R | At least 2 months of rasagiline Receives: Drug: Group R Rasagiline | |
| Group AD | At least 2 months of Anti-PD and Rasagiline Receives: Drug: Group AD Anti-PD + Antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serotonin SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Smith, MD, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955604
- Sponsor's protocol ID
- TVP-1012/PM102 CR
- Acronym
- STACCATO
- Status last verified
- Feb 2017
- First submitted
- 6 Aug 2009
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00955604
- Acronym / sponsor ID
- STACCATO / TVP-1012/PM102 CR
- Conditions
- Serotonin Syndrome
- Keywords
- Parkinson's Disease, Serotonin Toxicity, Rasagiline, Antidepressants, Chart Review, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group R+AD | – | Drug: Group R+AD Rasagiline + AntidepressantGroup R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days |
| Group R | – | Drug: Group R RasagilineAt least 2 months of rasagiline |
| Group AD | – | Drug: Group AD Anti-PD + AntidepressantAt least 2 months of Anti-PD and Rasagiline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- In addition to the above criteria, each group has specific inclusion criteria stated below:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group R+AD Rasagiline + AntidepressantAlso: AzilectRasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days | Drug | Group R+AD |
| Group R RasagilineAlso: AzilectAt least 2 months of rasagiline | Drug | Group R |
| Group AD Anti-PD + AntidepressantAn approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication. | Drug | Group AD |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Smith, MD study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Serotonin Syndrome, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.