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Completed

NCT Number: NCT00605813

Special Investigation Of Long Term Use Of Sertraline.

Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" 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 regarding long time use.

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Key information

Conditions

Depression Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Panic Disorder

Sex eligibility

All sexes

Study type

Observational

About this study

All the patients for 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

The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

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 A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration.

Other names: J Zoloft, Zoloft

Primary outcomes

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

    Time frame: Baseline up to 52 weeks

  2. 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.

Secondary outcomes

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

    Time frame: Baseline up to 52 weeks

    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor

  2. 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 Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor

  3. Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies

    Time frame: Baseline up to 52 weeks

    Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor

  4. Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)

    Time frame: Baseline up to 52 weeks

    Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Special Investigation Of Long Term Use Of J ZOLOFT.

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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