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

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677352
• Other study ID #: A0501088
• Status: Completed
• Phase: Phase 4
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Disease
• Panic Disorder

Intervention

Drug:
• sertraline
dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
• Paroxetine
dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Fujisawa-city	Kanagawa
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka
Japan	Pfizer Investigational Site	Higashiibaraki-gun	Ibaraki
Japan	Pfizer Investigational Site	Kawaguchi-shi	Saitama
Japan	Pfizer Investigational Site	Kita-ku	Tokyo
Japan	Pfizer Investigational Site	Kitakyushu-shi	Fukuoka
Japan	Pfizer Investigational Site	Kitakyusyu-shi	Fukuoka
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Minato-ku
Japan	Pfizer Investigational Site	Musashino	Tokyo
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Nakano-Ku	Tokyo
Japan	Pfizer Investigational Site	Nakano-ku	Yokohama
Japan	Pfizer Investigational Site	Nakanoku	Tokyo
Japan	Pfizer Investigational Site	Sagamihara-Shi	Kanagawa
Japan	Pfizer Investigational Site	Saitama city	Saitama
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo-Shi	Hokkaido
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Shinjuku-ku	Tokyo
Japan	Pfizer Investigational Site	Toshima-ku	Tokyo
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yokohama-Shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 12 weeks
Secondary	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".	12 weeks
Secondary	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.	Baseline and 12 weeks
Secondary	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.	Baseline and 12 weeks
Secondary	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.	1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug
Secondary	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.	4 weeks
Secondary	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.	4 weeks

External Links

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