Drug Use Investigation of Jzoloft.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Drug Use Investigation of Jzoloft.

Conditions
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Panic Disorder, Depression

Intervention / Treatment
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* Drug: Sertraline hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance. Exclusion Criteria: Patients not taking Sertraline hydrochloride.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sertraline hydrochloride.<br>Patients taking Sertraline hydrochloride. | Drug: Sertraline hydrochloride<br>* J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan. Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms. Duration: According to the protocol of A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration.<br>* Other names: J Zoloft, Zoloft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants of Treatment Related Adverse Events (TRAEs) | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | Baseline up to 16 weeks | 
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert |  | Baseline up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) | Baseline up to 16 weeks | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) | Baseline up to 16 weeks | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor | Baseline up to 16 weeks | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor | Baseline up to 16 weeks | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor | Baseline up to 16 weeks | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor | Baseline up to 16 weeks | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | Number of participants with responders of Sertraline to determine whether target disease severity is significant factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride | Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient | Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | Number of participants with responders of Sertraline to determine whether with or without complication is significant factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not | Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: Age | Number of participants with responders of Sertraline to determine whether age is significant factor | Baseline up to 16 weeks | 
| Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor | Baseline up to 16 weeks |