Status:
COMPLETED
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Panic Disorder
Eligibility:
All Genders
20-64 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00677352
Start Date
May 1 2008
End Date
February 1 2010
Last Update
January 27 2021
Active Locations (22)
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1
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
2
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
3
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka, Japan
4
Pfizer Investigational Site
Kitakyusyu-shi, Fukuoka, Japan