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

NCT00677352 | Completed Phase 4 Results

• 1 other identifier: A0501088
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Panic Disorder

Keywords

Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase

  Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.

  Baseline and 12 weeks

Secondary Outcomes (6)

• Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement

  12 weeks

• Mean Change From Baseline in Panic Attack at the End of Treatment Phase

  Baseline and 12 weeks

• Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase

  Baseline and 12 weeks

• Number of Participants With Summary of Adverse Events in Treatment Phase

  1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug

• Summary of Adverse Events in Tapering Phase

  4 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: sertraline

2

ACTIVE COMPARATOR

Drug: Paroxetine

Interventions

sertraline DRUG

dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks

Also known as: Zoloft, JZoloft

1

Paroxetine DRUG

dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks

Also known as: Paxil

2

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (22)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyusyu-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Higashiibaraki-gun, Ibaraki, Japan

Location

Pfizer Investigational Site

Fujisawa, Kanagawa, Japan

Location

Pfizer Investigational Site

Sagamihara-Shi, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Kawaguchi-shi, Saitama, Japan

Location

Pfizer Investigational Site

Saitama, Saitama, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Kita-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Musashino, Tokyo, Japan

Location

Pfizer Investigational Site

Nakano-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Nakanoku, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Nakano, Yokohama, Japan

Location

Pfizer Investigational Site

Minatoku, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Panic Disorder

Interventions

Sertraline; Paroxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 14, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 27, 2021
• Results First Posted: May 6, 2011

Record last verified: 2021-01

Locations

JP (22)