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

Condition(s) targeted: Panic Disorder

Intervention: sertraline (Drug); Paroxetine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Primary outcome: Mean change from baseline in Panic and Agoraphobia Scale (PAS) total score at the end of treatment (Week 12)

Secondary outcome:

Clinical Global Impression of Improvement (CGI-I)

Frequency of panic attack

HAM-A total score

Adverse events

Antidepressant Discontinuation Scale (ADDS)

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient who meets diagnosis of Panic Disorder (with or without Agoraphobia) according

to 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, MDD, OCD, SAD or 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Minato-ku, Japan; Recruiting

Pfizer Investigational Site, Nagoya, Aichi, Japan; Recruiting

Pfizer Investigational Site, Kitakyushu-shi, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Fukuoka-shi, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Kitakyusyu-shi, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Sapporo-Shi, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Sapporo, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Higashiibaraki-gun, Ibaraki, Japan; Recruiting

Pfizer Investigational Site, Yokohama-Shi, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Sagamihara-Shi, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Fujisawa-city, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Yokohama, Kanagawa, Japan; Recruiting

Pfizer Investigational Site, Kawaguchi-shi, Saitama, Japan; Recruiting

Pfizer Investigational Site, Saitama city, Saitama, Japan; Recruiting

Pfizer Investigational Site, Toshima-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Minato-ku, Tokyo, Japan; Terminated

Pfizer Investigational Site, Kita-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Minato-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Shinjuku-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Nakanoku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Nakano-Ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Musashino, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Chiyoda-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Nakano-ku, Yokohama, Japan; Recruiting

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

Starting date: May 2008
Ending date: March 2010
Last updated: October 9, 2009