Panic DisorderPhase 4NCT00677352

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

A Phase 4 study testing sertraline and Paroxetine in people with Panic Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder. Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Panic Disorder
What is being tested?: sertraline and Paroxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 321 participants
Where: 22 sitesJapan
Study dates: May 2008to Feb 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient who meets diagnosis of Panic Disorder (with or without Agoraphobia) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
Patients must have experienced at least 4 panic attacks within 4 weeks before screening.
At baseline patients with Panic Disorder of total score of 18 or higher on the Panic and Agoraphobia scale (clinician rated version).

Who cannot join

Patients who concurrently have bipolar disorder, schizophrenia, delusional disorder, epilepsy, Major Depression Disorder (MDD), Obsessive Compulsive Disorder (OCD), Seasonal Affective Disorder (SAD) or General Anxiety Disorder (GAD) according to the DSM-IV criteria.
Patients who concurrently have depression/depressive state, anxiety disorder and generalized anxiety disorder may be included in the study if the primary diagnosis is identified to be panic disorder
Patients with the total score of at least 18 on the Hamilton Depression Rating Scale (HAM-D) (Items 1 to 17) at the start of Screening (Visit 1)
Patients who require concomitant drug therapy with psychotropic agents (including benzodiazepines) and monoamine oxidase inhibitor during the period of the study.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Japan22 sites

Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Fujisawa, Kanagawa
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Higashiibaraki-gun, Ibaraki
Pfizer Investigational Site
Kawaguchi-shi, Saitama
Pfizer Investigational Site
Kita-ku, Tokyo
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka
Pfizer Investigational Site
Kitakyusyu-shi, Fukuoka
Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Minatoku
Pfizer Investigational Site
Musashino, Tokyo
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Nakano, Yokohama
Pfizer Investigational Site
Nakano-Ku, Tokyo
Pfizer Investigational Site
Nakanoku, Tokyo
Pfizer Investigational Site
Sagamihara-Shi, Kanagawa
Pfizer Investigational Site
Saitama, Saitama
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Toshima-ku, Tokyo
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.

Conditions: Panic Disorder
Being tested: sertraline, Paroxetine
Keywords: Panic Disorder
Medical subject headings: Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sertralineDrug
Also called Zoloft, JZoloft
dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
ParoxetineDrug
Also called Paxil
dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Study groups in NCT00677352
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: sertraline
2	Active comparator	Not described Receives: Drug: Paroxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
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.
Measured: Baseline and 12 weeks

Secondary outcomes (6)

Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement
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".
Measured: 12 weeks
Mean Change From Baseline in Panic Attack at the End of Treatment Phase
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.
Measured: Baseline and 12 weeks
Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase
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.
Measured: Baseline and 12 weeks
Number of Participants With Summary of Adverse Events in Treatment Phase
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.
Measured: 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug
Summary of Adverse Events in Tapering Phase
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.
Measured: 4 weeks
Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase
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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Feb 2010

First posted14 May 2008 (estimated)
Study startMay 2008
Primary completionJan 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Panic DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00677352
Sponsor's protocol ID: A0501088
Status last verified: Jan 2021
First submitted: 9 May 2008
Last updated: 27 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
ClinicalTrials.gov ID: NCT00677352
Acronym / sponsor ID: A0501088
Conditions: Panic Disorder
Keywords: Panic Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jan 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 14 May 2008 (estimated)
Results: Posted 6 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: sertraline
2	Active comparator	Drug: Paroxetine

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patient who meets diagnosis of Panic Disorder (with or without Agoraphobia) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
Patients must have experienced at least 4 panic attacks within 4 weeks before screening.
At baseline patients with Panic Disorder of total score of 18 or higher on the Panic and Agoraphobia scale (clinician rated version).

Key exclusion criteria (4 listed)

Patients who concurrently have bipolar disorder, schizophrenia, delusional disorder, epilepsy, Major Depression Disorder (MDD), Obsessive Compulsive Disorder (OCD), Seasonal Affective Disorder (SAD) or General Anxiety Disorder (GAD) according to the DSM-IV criteria.
Patients who concurrently have depression/depressive state, anxiety disorder and generalized anxiety disorder may be included in the study if the primary diagnosis is identified to be panic disorder
Patients with the total score of at least 18 on the Hamilton Depression Rating Scale (HAM-D) (Items 1 to 17) at the start of Screening (Visit 1)
Patients who require concomitant drug therapy with psychotropic agents (including benzodiazepines) and monoamine oxidase inhibitor during the period of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sertralineAlso: Zoloft, JZoloftdosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks	Drug	1
ParoxetineAlso: Paxildosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks	Drug	2

Primary outcome

Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
Time frame: 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.

6 secondary outcomes

Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement
Time frame: 12 weeks
Mean Change From Baseline in Panic Attack at the End of Treatment Phase
Time frame: Baseline and 12 weeks
Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase
Time frame: Baseline and 12 weeks
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
Summary of Adverse Events in Tapering Phase
Time frame: 4 weeks
Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase
Time frame: 4 weeks

Results and safety

Results posted to the registry on 6 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sertraline	157	132
Paroxetine	164	122

Primary outcome: Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase

Time frame: Baseline and 12 weeks. Least squares mean (95% Confidence Interval). Unit: Scores on scale

Measure	Sertraline n = 127	Paroxetine n = 127
Value	-17.4 (-18.9 to -15.9)	-17.0 (-18.4 to -15.5)

Sertraline vs Paroxetine: Mean Difference (Final Values): -0.4 (95% CI -2.5 to 1.6), ANCOVA

Population analysed: 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

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sertraline	2 of 157 (1.3%)	132 of 157 (84.1%)	Not reported
Paroxetine	1 of 162 (0.6%)	137 of 162 (84.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sertraline and Paroxetine in people with Panic Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00677352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.