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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00677352
First received: May 9, 2008
Last updated: May 17, 2011
Last verified: May 2011

May 9, 2008
May 17, 2011
May 2008
January 2010   (final data collection date for primary outcome measure)
Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
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.
Mean change from baseline in Panic and Agoraphobia Scale (PAS) total score at the end of treatment (Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00677352 on ClinicalTrials.gov Archive Site
  • Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Frequency of panic attack [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • HAM-A total score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Antidepressant Discontinuation Scale (ADDS) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00677352
A0501088
No
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