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

NCT00677352

Last updated date
Study Location
Pfizer Investigational Site
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Official Title  ICMJE A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Brief Summary To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE
  • Drug: sertraline
    dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks
    Other Name: Zoloft, JZoloft
  • Drug: Paroxetine
    dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks
    Other Name: Paxil
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: sertraline
  • Active Comparator: 2
    Intervention: Drug: Paroxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2010)
321
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2008)
320
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00677352
Other Study ID Numbers  ICMJE A0501088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP