Special Investigation Of J Zoloft For Panic Disorder Patients
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Panic Disorder
Intervention: Sertraline hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The objective of this surveillance is to collect information for panic disorder patients
about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions),
2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered
to affect the safety and/or efficacy of this drug.
Clinical Details
Official title: Special Investigation Of J Zoloft For Panic Disorder Patients
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of Participants of Treatment Related Adverse Events (TRAEs)Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Secondary outcome: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting DoseRisk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug Factors Considered to Affect the Efficacy of Sertraline: Complication Factors Considered to Affect the Efficacy of Sertraline: Drinking Status
Detailed description:
All patients with panic disorder to whom an investigator prescribes the first sertraline
hydrochloride should be registered consecutively until the number of subjects reaches target
number in order to extract patients enrolled into the investigation at random.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients with panic disorder need to be taking sertraline hydrochloride in order to be
enrolled in the surveillance.
Exclusion Criteria:
Patients not taking sertraline hydrochloride.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2007
Last updated: August 20, 2012
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