Phase 4
Completed N=321
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Source: ClinicalTrials.gov NCT00677352 ↗Enrolled (actual)
321
Serious AEs
0.9%
Results posted
May 2011
Primary outcomePrimary: Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase — -17.4; -17.0 Scores on scale
Summary
To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase |
-17.4; -17.0 | — |
| SECONDARY Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement |
83.5; 85.0 | — |
| SECONDARY Mean Change From Baseline in Panic Attack at the End of Treatment Phase |
-4.07; -4.59 | — |
| SECONDARY Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase |
-11.35; -10.36 | — |
| SECONDARY Number of Participants With Summary of Adverse Events in Treatment Phase |
127; 134; 1; 1; 3; 14 | — |
| SECONDARY Summary of Adverse Events in Tapering Phase |
73; 87; 1; 0; 11; 16 | — |
| SECONDARY Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase |
59.7; 76.3 | 0.0062 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00677352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.