NCT00677352CompletedPhase 4
A Randomized, Double-Blind, Multicenter Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country321 target enrollmentStarted: May 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
Study Overview
Brief Summary
To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: sertraline (Drug)
2
Active Comparator
Intervention: Paroxetine (Drug)
Outcomes
Primary Outcomes
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
- Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement(12 weeks)
- Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase(Baseline and 12 weeks)
- Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase(4 weeks)
- Mean Change From Baseline in Panic Attack at the End of Treatment Phase(Baseline and 12 weeks)
- Summary of Adverse Events in Tapering Phase(4 weeks)
- Number of Participants With Summary of Adverse Events in Treatment Phase(1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug)
Investigators
Study Sites (1)
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