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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 
Overall Participants Analyzed 
[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 
[1] The target disease which was diagnosed by investigator
Target Disease Severity [1] 
[Units: Participants]
 
Mild   111 
Moderate   362 
Severe   44 
[1] The severity of target disease which was diagnosed by investigator
Complications [1] 
[Units: Participants]
 
Present   198 
Absent   319 
[1] 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.)
Concomitant Drug [1] 
[Units: Participants]
 
Present   470 
Absent   47 
[1] 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.)
Starting Dose [1] 
[Units: Participants]
 
25 mg   348 
50 mg   144 
75 mg   10 
100 mg   6 
Other than those Above   9 
[1] 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



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