Clinical trial NCT00677352: A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Official title: A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Disorder
Keywords: Panic Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-14
Enrollment: 321
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement
timeFrame: 12 weeks
measure: Mean Change From Baseline in Panic Attack at the End of Treatment Phase
timeFrame: Baseline and 12 weeks
measure: Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase
timeFrame: Baseline and 12 weeks
measure: Number of Participants With Summary of Adverse Events in Treatment Phase
timeFrame: 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug
measure: Summary of Adverse Events in Tapering Phase
timeFrame: 4 weeks
measure: Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyusyu-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Sapporo-Shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Higashiibaraki-gun
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Fujisawa-city
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sagamihara-Shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Kawaguchi-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Saitama city
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kita-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Musashino
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakanoku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Pfizer Investigational Site
state: Yokohama
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: