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Study Evaluating Venlafaxine ...

Study Evaluating Venlafaxine ER in Patients With Panic Disorder

Last Updated: 2009-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-04-30

Brief Summary

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The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in comparison to those of placebo.

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Detailed Description

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Conditions

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Panic Disorder

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Venlafaxine ER

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1
* Have sufficient symptoms to require anxiolytic drug therapy
* Have a score ≥4 on the Clinical Global Impressions Scale (CGI) severity of illness item at screening and baseline

Exclusion Criteria

* Known hypersensitivity to venlafaxine (IR or ER), related compounds, or paroxetine
* History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma \[except basal cell epithelioma\], uncontrolled hypertension)
* Clinically important abnormality on screening physical examination, vital signs, electrocardiogram (ECG), laboratory tests or urine drug screen

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers