Clinical trial NCT00605865: Drug Use Investigation of Jzoloft.
Official title: Drug Use Investigation of Jzoloft.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Panic Disorder
Depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 2272
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 A0501090 prescribes sertraline hydrochloride.

Brief summary: The objective of this surveillance is to collect information 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 the patients 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 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 16 weeks
measure: Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
timeFrame: Baseline up to 16 weeks
Secondary outcomes:
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
timeFrame: Baseline up to 16 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
timeFrame: Baseline up to 16 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
timeFrame: Baseline up to 16 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 16 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
timeFrame: Baseline up to 16 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)
timeFrame: Baseline up to 16 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Age
timeFrame: Baseline up to 16 weeks
measure: Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)
timeFrame: Baseline up to 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: