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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00677352
First received: May 9, 2008
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Panic Disorder
Drug: sertraline
Drug: Paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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".


  • Mean Change From Baseline in Panic Attack at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Summary of Adverse Events in Tapering Phase [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 321
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: sertraline
dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
Other Name: Zoloft, JZoloft
Active Comparator: 2 Drug: Paroxetine
dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks
Other Name: Paxil

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677352

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka, Japan
Pfizer Investigational Site
Kitakyusyu-shi, Fukuoka, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Sapporo-Shi, Hokkaido, Japan
Pfizer Investigational Site
Higashiibaraki-gun, Ibaraki, Japan
Pfizer Investigational Site
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
Kawaguchi-shi, Saitama, Japan
Pfizer Investigational Site
Saitama city, Saitama, Japan
Pfizer Investigational Site
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
Nakano-ku, Yokohama, Japan
Pfizer Investigational Site
Minato-ku, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Keywords provided by Pfizer:
Panic Disorder

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Paroxetine
Sertraline
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014