A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00677352

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Panic Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride Sertraline hydrochloride Sertraline Paroxetine Mesylate

U.S. FDA Resources

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 (Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Frequency of panic attack [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Antidepressant Discontinuation Scale (ADDS) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: sertraline dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
2: Active Comparator	Drug: Paroxetine dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

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

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

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0501088
Study First Received:	May 9, 2008
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00677352 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Panic Disorder

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Paroxetine
Serotonin Uptake Inhibitors
Pharmacologic Actions
Panic Disorder

Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Sertraline
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 09, 2010