A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00677352
First received: May 9, 2008
Last updated: May 17, 2011
Last verified: May 2011
Results First Received: January 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Panic Disorder
Interventions: Drug: sertraline
Drug: Paroxetine

  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
Participants were screened at 34 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who experienced at least one panic attack that met the DSM-IV diagnostic criteria per week between the start of the washout/observation period and the start of the double-blind treatment period and who had a total score of 18 or higher on the Panic and Agoraphobia Scale at the start of the double-blind treatment period.

Reporting Groups
  Description
Sertraline

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Paroxetine

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.


Participant Flow for 2 periods

Period 1:   Treatment Phase
    Sertraline     Paroxetine  
STARTED     157 [1]   164 [2]
COMPLETED     132     122  
NOT COMPLETED     25     42  
Adverse Event                 14                 22  
Lack of Efficacy                 2                 3  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 7                 7  
Physician Decision                 1                 0  
Pregnancy                 0                 1  
Protocol Violation                 1                 1  
Transference or work related matter                 0                 5  
Not treated                 0                 2  
[1] All 157 subjects were treated with Sertraline.
[2] 2 subjects were not teated, therefore 162 subjects were treated with paroxetine.

Period 2:   Tapering Phase
    Sertraline     Paroxetine  
STARTED     132     122  
COMPLETED     126     112  
NOT COMPLETED     6     10  
Adverse Event                 1                 5  
Withdrawal by Subject                 5                 3  
Pregnancy                 0                 1  
Job transfer                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Sertraline

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Paroxetine

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Total Total of all reporting groups

Baseline Measures
    Sertraline     Paroxetine     Total  
Number of Participants  
[units: participants]
  157     162     319  
Age, Customized  
[units: participants]
     
< 18 years     0     0     0  
18 - 44 years     119     126     245  
45 -64 years     38     36     74  
>= 65 years     0     0     0  
Gender  
[units: participants]
     
Female     113     109     222  
Male     44     53     97  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement   [ Time Frame: 12 weeks ]

3.  Secondary:   Mean Change From Baseline in Panic Attack at the End of Treatment Phase   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Number of Participants With Summary of Adverse Events in Treatment Phase   [ Time Frame: 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug ]

6.  Secondary:   Summary of Adverse Events in Tapering Phase   [ Time Frame: 4 weeks ]

7.  Secondary:   Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00677352     History of Changes
Other Study ID Numbers: A0501088
Study First Received: May 9, 2008
Results First Received: January 19, 2011
Last Updated: May 17, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare