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

Viatris

Status and phase: Completed; Phase 4

Conditions: Panic Disorder

Treatments: Drug: Paroxetine; Drug: sertraline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677352

A0501088

Details and patient eligibility

About

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

Enrollment: 321 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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321 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: sertraline

2

Active Comparator group

Treatment:

Drug: Paroxetine