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
Results First Received: August 9, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Depression
Panic Disorder
Intervention: Drug: Sertraline hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sertraline Participants taking Sertraline according to Japanese Package Insert

Participant Flow:   Overall Study
    Sertraline  
STARTED     542  
COMPLETED     517  
NOT COMPLETED     25  
Protocol Violation                 25  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sertraline Participants taking Sertraline according to Japanese Package Insert

Baseline Measures
    Sertraline  
Number of Participants  
[units: participants]
  517  
Age, Customized  
[units: participants]
 
<65 years     447  
>=65 years     70  
Gender  
[units: participants]
 
Female     311  
Male     206  
Target Disease [1]
[units: participants]
 
Depression/Depressed State     426  
Panic Disorder     44  
Depression/Depressed State and Panic Disorder     21  
Other than those Above     26  
Target Disease Severity [2]
[units: participants]
 
Mild     111  
Moderate     362  
Severe     44  
Complications [3]
[units: participants]
 
Present     198  
Absent     319  
Concomitant Drug [4]
[units: participants]
 
Present     470  
Absent     47  
Starting Dose [5]
[units: participants]
 
25 mg     348  
50 mg     144  
75 mg     10  
100 mg     6  
Other than those Above     9  
[1] The target disease which was diagnosed by investigator
[2] The severity of target disease which was diagnosed by investigator
[3] Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)
[4] Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)
[5] Starting dose of each participant enrolled in this study



  Outcome Measures
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1.  Primary:   Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert   [ Time Frame: Baseline up to 52 weeks ]

2.  Primary:   Number of Participants of Treatment Related Adverse Events (TRAEs)   [ Time Frame: Baseline up to 52 weeks ]

3.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction   [ Time Frame: Baseline up to 52 weeks ]

4.  Secondary:   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 ]

5.  Secondary:   Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies   [ Time Frame: Baseline up to 52 weeks ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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