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

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ClinicalTrials.gov Identifier: NCT00677352
Recruitment Status : Completed
First Posted : May 14, 2008
Results First Posted : May 6, 2011
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE May 9, 2008
First Posted Date  ICMJE May 14, 2008
Results First Submitted Date  ICMJE January 19, 2011
Results First Posted Date  ICMJE May 6, 2011
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE May 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2008)
Mean change from baseline in Panic and Agoraphobia Scale (PAS) total score at the end of treatment (Week 12) [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement [ Time Frame: 12 weeks ]
    The ratings were rated to compare with baseline by 7-point " 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse". Responder was defined as number of participants who were assessed as "very much improved" or " much improved".
  • Mean Change From Baseline in Panic Attack at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ]
    Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.
  • Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ]
    The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items. The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52.
  • 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 ]
    Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.
  • Summary of Adverse Events in Tapering Phase [ Time Frame: 4 weeks ]
    Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.
  • Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase [ Time Frame: 4 weeks ]
    The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2008)
  • Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 16 weeks ]
  • Frequency of panic attack [ Time Frame: 16 weeks ]
  • HAM-A total score [ Time Frame: 16 weeks ]
  • Adverse events [ Time Frame: 16 weeks ]
  • Antidepressant Discontinuation Scale (ADDS) [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

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