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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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: Mean change from baseline in Panic and Agoraphobia Scale (PAS) total score at the end of treatment (Week 12) [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Pfizer

Dates:
Date Received: May 9, 2008
Date Started: May 2008
Date Completion:
Last Updated: May 17, 2011
Last Verified: May 2011