Overview

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

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Paroxetine
Sertraline
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.