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

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

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.

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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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.

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.

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 ]

Show Outcome Measure 1

2. Secondary:

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

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3. Secondary:

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

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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 ]

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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 ]

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6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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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