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Completed

NCT Number: NCT00677352

A 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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline

Drug

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

Other names: Zoloft, JZoloft

paroxetine

Drug

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

Other names: Paxil

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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".

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 14, 2008
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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