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Completed

NCT Number: NCT00605917

Special Investigation Of J Zoloft For Panic Disorder Patients

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sertraline hydrochloride

Drug

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 A0501092, the duration of the investigation for findings regarding safety and efficacy of a panic disorder patient is from the first drug administration to the 16 weeks after the first administration.

Other names: J Zoloft, Zoloft

Primary outcomes

  1. Number of Participants of Treatment Related Adverse Events (TRAEs)

    Time frame: Baseline up to 52 weeks

    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.

  2. Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert

    Time frame: Baseline up to 52 weeks

Secondary outcomes

  1. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor

  2. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug

    Time frame: Baseline up to 52 weeks

    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.)

  3. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor

  4. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor

  5. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness

    Time frame: Baseline up to 52 weeks

    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

  6. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor

  7. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor

  8. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor

  9. Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications

    Time frame: Baseline up to 52 weeks

    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.)

  10. Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug

    Time frame: Baseline up to 52 weeks

    Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor

  11. Factors Considered to Affect the Efficacy of Sertraline: Complication

    Time frame: Baseline up to 52 weeks

    Number of participants with responders of Sertraline to determine whether with or without complication is significant 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.)

  12. Factors Considered to Affect the Efficacy of Sertraline: Drinking Status

    Time frame: Baseline up to 52 weeks

    Number of participants with responders of Sertraline to determine whether drinking status is significant factor

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 31, 2008
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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