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.

Study Type: Interventional

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

Study Primary Completion Date: February 2010

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 (Week 12)
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Clinical Global Impression of Improvement (CGI-I)
  • Time Frame: 16 weeks
    Safety Issue?: No
• Frequency of panic attack
  • Time Frame: 16 weeks
    Safety Issue?: No
• HAM-A total score
  • Time Frame: 16 weeks
    Safety Issue?: No
• Adverse events
  • Time Frame: 16 weeks
    Safety Issue?: Yes
• Antidepressant Discontinuation Scale (ADDS)
  • Time Frame: 16 weeks
    Safety Issue?: Yes

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.

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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on July 02, 2009

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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