Special Investigation Of Long Term Use Of Sertraline.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00605813
First received: January 18, 2008
Last updated: August 9, 2012
Last verified: August 2012

January 18, 2008
August 9, 2012
September 2007
September 2011   (final data collection date for primary outcome measure)
  • Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert [ Time Frame: Baseline up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants of Treatment Related Adverse Events (TRAEs) [ Time Frame: Baseline up to 52 weeks ] [ Designated as safety issue: Yes ]
    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.
  • The incidence of adverse drug reactions. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00605813 on ClinicalTrials.gov Archive Site
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction [ Time Frame: Baseline up to 52 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor
  • 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 ] [ Designated as safety issue: Yes ]
    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
  • Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies [ Time Frame: Baseline up to 52 weeks ] [ Designated as safety issue: No ]
    Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor
  • 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 ] [ Designated as safety issue: No ]
    Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor
This study is a non-interventional/observational study and does not have any secondary outcomes measures. [ Time Frame: There are no secondary outcomes for this study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Special Investigation Of Long Term Use Of Sertraline.
Special Investigation Of Long Term Use Of J ZOLOFT.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.

  • Depression
  • Panic Disorder
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.

Other Name: J Zoloft, Zoloft
Sertraline hydrochloride.
Patients taking Sertraline hydrochloride.
Intervention: Drug: Sertraline hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
542
September 2011
September 2011   (final data collection date for primary outcome measure)

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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00605813
A0501091
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP