Special Investigation Of Long Term Use Of Sertraline.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression Panic Disorder |
Drug: Sertraline hydrochloride |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Special Investigation Of Long Term Use Of J ZOLOFT. |
- 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.
- 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
| Enrollment: | 542 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (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. Other Name: J Zoloft, Zoloft
|
Detailed 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00605813 History of Changes |
| Other Study ID Numbers: | A0501091 |
| Study First Received: | January 18, 2008 |
| Results First Received: | August 9, 2012 |
| Last Updated: | August 9, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Panic Disorder Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013