Clinical trial NCT00605917: Special Investigation Of J Zoloft For Panic Disorder Patients
Official title: Special Investigation Of J Zoloft For Panic Disorder Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Panic Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 997
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients to whom an investigator involved in A0501092 prescribes sertraline hydrochloride.

Brief 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.

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 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.

Primary outcomes:
measure: Number of Participants of Treatment Related Adverse Events (TRAEs)
timeFrame: Baseline up to 52 weeks
measure: Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
timeFrame: Baseline up to 52 weeks
Secondary outcomes:
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
timeFrame: Baseline up to 52 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
timeFrame: Baseline up to 52 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug
timeFrame: Baseline up to 52 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Complication
timeFrame: Baseline up to 52 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Drinking Status
timeFrame: Baseline up to 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: