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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nagoya, Aichi, Japan
Contact
1-800-718-1021
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.

NCT00677352
Pfizer
Completed
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

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A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Panic Disorder
  • 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
  • Experimental: 1
    Intervention: Drug: sertraline
  • Active Comparator: 2
    Intervention: Drug: Paroxetine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
February 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00677352
A0501088
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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