Trial · NCT00677352

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

NCT00677352, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-05-06

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ConductScience Library. A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder. Trials, record NCT00677352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00677352

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
NCT number: NCT00677352
Status: Completed
Phases: Phase 4
Enrollment: 321 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Panic Disorder
Interventions: sertraline, Paroxetine
First posted: 2008-05-14
Last updated: 2021-01-27
Results first posted: 2011-05-06

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase	Baseline and 12 weeks	Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.
Secondary	Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement	12 weeks	The ratings were rated to compare with baseline by 7-point " 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse". Responder was defined as number of participants who were assessed as "very much improved" or " much improved".
Secondary	Mean Change From Baseline in Panic Attack at the End of Treatment Phase	Baseline and 12 weeks	Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.
Secondary	Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase	Baseline and 12 weeks	The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items. The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52.
Secondary	Number of Participants With Summary of Adverse Events in Treatment Phase	1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug	Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.
Secondary	Summary of Adverse Events in Tapering Phase	4 weeks	Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.
Secondary	Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase	4 weeks	The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase	Baseline and 12 weeks	Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward	Scores on scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement	12 weeks	Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward	Percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline in Panic Attack at the End of Treatment Phase	Baseline and 12 weeks	Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward	panic attacks per week	MEAN
SECONDARY	Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase	Baseline and 12 weeks	Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward	Scores on a scale	MEAN
SECONDARY	Number of Participants With Summary of Adverse Events in Treatment Phase	1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug	The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.	Participants	NUMBER
SECONDARY	Summary of Adverse Events in Tapering Phase	4 weeks	The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.	Participants	NUMBER
SECONDARY	Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase	4 weeks	Completer Set : Subset of patients in the EES who had a PAS rating at Week 16.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase	Sertraline		-17.4	95% Confidence Interval -18.9 to -15.9	Scores on scale
Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase	Paroxetine		-17.0	95% Confidence Interval -18.4 to -15.5	Scores on scale
Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement	Sertraline		83.5		Percentage of participants
Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement	Paroxetine		85.0		Percentage of participants
Mean Change From Baseline in Panic Attack at the End of Treatment Phase	Sertraline		-4.07	Standard Deviation 6.12	panic attacks per week
Mean Change From Baseline in Panic Attack at the End of Treatment Phase	Paroxetine		-4.59	Standard Deviation 7.52	panic attacks per week
Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase	Sertraline		-11.35	Standard Deviation 10.45	Scores on a scale
Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase	Paroxetine		-10.36	Standard Deviation 8.27	Scores on a scale
Number of Participants With Summary of Adverse Events in Treatment Phase	Sertraline	Subjects with adverse events	127		Participants
Number of Participants With Summary of Adverse Events in Treatment Phase	Paroxetine	Subjects with adverse events	134		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Phase	STARTED	Sertraline	157
Treatment Phase	STARTED	Paroxetine	164
Treatment Phase	COMPLETED	Sertraline	132
Treatment Phase	COMPLETED	Paroxetine	122
Treatment Phase	NOT COMPLETED	Sertraline	25
Treatment Phase	NOT COMPLETED	Paroxetine	42
Tapering Phase	STARTED	Sertraline	132
Tapering Phase	STARTED	Paroxetine	122
Tapering Phase	COMPLETED	Sertraline	126
Tapering Phase	COMPLETED	Paroxetine	112

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events86

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Palpitations	Cardiac disorders	Sertraline	7	157
other	Palpitations	Cardiac disorders	Paroxetine	10	162
other	Tachycardia	Cardiac disorders	Sertraline	5	157
other	Tachycardia	Cardiac disorders	Paroxetine	13	162
other	Tinnitus	Ear and labyrinth disorders	Sertraline	1	157
other	Tinnitus	Ear and labyrinth disorders	Paroxetine	10	162
other	Vertigo	Ear and labyrinth disorders	Sertraline	7	157
other	Vertigo	Ear and labyrinth disorders	Paroxetine	21	162
other	Abdominal discomfort	Gastrointestinal disorders	Sertraline	7	157
other	Abdominal discomfort	Gastrointestinal disorders	Paroxetine	6	162

1 to 10 of 86Source ClinicalTrials.gov

See all 86 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sertraline
Total, all-cause mortality	Paroxetine
Total, other adverse events	Sertraline	132	157
Total, other adverse events	Paroxetine	137	162
Total, serious adverse events	Sertraline	2	157
Total, serious adverse events	Paroxetine	1	162

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Sertraline vs Paroxetine: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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