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

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

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

Conditions
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Panic Disorder

Intervention / Treatment
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* Drug: sertraline
* Drug: Paroxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: sertraline<br>* dosage : 25mg , 50mg , placebo; dosage form : tablet; frequency : once daily after dinner; duration : 14 weeks<br>* Other names: Zoloft, JZoloft;|
| Active Comparator: 2<br> | Drug: Paroxetine<br>* dosage : 10mg, placebo; dosage form : capsule; frequency : once daily after dinner; duration : 14 weeks<br>* Other names: Paxil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement | 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. | 12 weeks | 
| Mean Change From Baseline in Panic Attack at the End of Treatment Phase | 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. | Baseline and 12 weeks | 
| Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase | 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. | Baseline and 12 weeks | 
| Number of Participants With Summary of Adverse Events in Treatment Phase | 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. | 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug | 
| Summary of Adverse Events in Tapering Phase | 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. | 4 weeks | 
| Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic Disorder