Special Investigation Of Long Term Use Of Sertraline.

Depression Clinical Trial

Official title:

Special Investigation Of Long Term Use Of J ZOLOFT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605813
• Other study ID #: A0501091
• Status: Completed
• Start date: September 2007
• Est. completion date: September 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Panic Disorder

Intervention

Drug:
• Sertraline hydrochloride
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert		Baseline up to 52 weeks
Primary	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 52 weeks
Secondary	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 Sertralinedine to determine whether with or without renal dysfunction is significant risk factor	Baseline up to 52 weeks
Secondary	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 Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor	Baseline up to 52 weeks
Secondary	Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies	Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor	Baseline up to 52 weeks
Secondary	Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)	Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor	Baseline up to 52 weeks

External Links

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