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

NCT ID: NCT00677352

Last Updated: 2021-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

sertraline

Intervention Type DRUG

dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks

2

Group Type ACTIVE_COMPARATOR

Paroxetine

Intervention Type DRUG

dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Interventions

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sertraline

dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks

Intervention Type DRUG

Paroxetine

dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Intervention Type DRUG

Other Intervention Names

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Zoloft, JZoloft Paxil

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyushu-shi, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyusyu-shi, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Higashiibaraki-gun, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Fujisawa, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Sagamihara-Shi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Kawaguchi-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Saitama, Saitama, Japan

Site Status

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Kita-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Musashino, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakano-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakanoku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakano, Yokohama, Japan

Site Status

Pfizer Investigational Site

Minatoku, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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A0501088

Identifier Type: -

Identifier Source: org_study_id

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