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

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Drug: sertraline; Drug: Paroxetine

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: sertraline; dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks; Other Names: Zoloft, JZoloft
Active Comparator: 2	Drug: Paroxetine; dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks; Other Names: Paxil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: May 9, 2008
• First Submitted That Met QC Criteria: May 13, 2008
• First Posted (Estimate): May 14, 2008

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Panic Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Anxiety Disorders; Disease; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Sertraline; Paroxetine
• Other Study ID Numbers: A0501088