A Comparison of Duloxetine Hydrochloride, Venlafaxine Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder

Eli Lilly and Company Limited0 sites560 target enrollmentMarch 3, 2005

DrugsYENTREVE EFEXOR CYMBALTA

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Eli Lilly and Company Limited
Enrollment: 560
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 3, 2005

End Date

March 5, 2007

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Eli Lilly and Company Limited

Eligibility Criteria

Inclusion Criteria

•Patients are eligible to be included in the study only if they meet all of the following criteria:
•\[1]Male and female outpatients at least 18 years of age presenting with generalized anxiety disorder (GAD) based on the disease diagnostic criteria (Section 4\.2\.1\). Patients must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.
•\[2]Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding; test negative for pregnancy at the time of enrollment based on a urine pregnancy test; and agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control: diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 week following the last dose of study drug.
•\[3]Must have a Clinical Global Impressions of Severity (CGI\-Severity) score \>\=4 at Visit 1 and Visit 2\.
•\[4]At Visit 1, patient must have a Covi Anxiety Scale (CAS) score \>\=9, no item in the Raskin Depression Scale (RDS) may be \>3, and the CAS must be greater than the RDS.
•\[5]Must have Hospital Anxiety and Depression Scale (HADS) anxiety subscale score \=10 at Visit 1\.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

•Patients will be excluded from the study if they meet any of the following criteria:
•\[6]Any current and primary DSM\-IV\-TR Axis I diagnosis other than GAD.
•·Patients diagnosed with or who have a history of major depressive disorder (MDD) within the past 6 months or
•·Patients diagnosed with or who have a history of panic disorder, post\-traumatic stress disorder (PTSD), or an eating disorder within the past year or
•·Patients who have been diagnosed with obsessive\-compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders during their lifetime.
•\[7]The presence of an Axis II disorder or history of antisocial behavior, which, in the judgment of the investigator, would interfere with compliance with the study protocol.
•\[8]Benzodiazepine use 14 days prior to Visit 2\.
•\[9]Patients judged clinically to be at serious suicidal risk, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study completion.
•\[10]Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
•\[11]Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine.