Special Investigation of Long Term Use of Sertraline. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00605813

Purpose

Special investigation of long term use of SERTRALINE, 52Week 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 to long time use.

Condition	Intervention	Phase
Depression Panic Disorder	Drug: Sertraline hydrochloride	Phase IV

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Special Investigation of Long Term Use of J ZOLOFT.

Resource links provided by NLM:

MedlinePlus related topics: Depression Panic Disorder

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The incidence of adverse drug reactions. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Sertraline hydrochloride. Patients taking Sertraline hydrochloride.	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.

Groups/Cohorts

Assigned Interventions

Sertraline hydrochloride.

Patients taking Sertraline hydrochloride.

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.

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605813

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0501091
Study First Received:	January 18, 2008
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00605813 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms

Panic Disorder
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009