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”

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

Intervention(s) in this Clinical Trial

• Drug: sertraline
  • dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
• Drug: Paroxetine
  • dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

Secondary Measures

• Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement
  • Time Frame: 12 weeks
    Safety Issue?: No
• Mean Change From Baseline in Panic Attack at the End of Treatment Phase
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Number of Participants With Summary of Adverse Events in Treatment Phase
  • Time Frame: 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug
    Safety Issue?: Yes
• Summary of Adverse Events in Tapering Phase
  • Time Frame: 4 weeks
    Safety Issue?: Yes
• Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00677352

Study ID Number: A0501088

ClinicalTrials.gov Identifier: NCT00677352

Health Authority: Japan: Ministry of Health, Labor and Welfare

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