Duloxetine for the Treatment of Generalized Anxiety Disorder

Phase 3CompletedNCT00803361

Eli Lilly and Company210 enrolled

Overview

This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Generalized Anxiety Disorder

Interventions

DuloxetineDRUG

60 to 120 mg, capsules, oral, once a day for 15 weeks

PlaceboDRUG

placebo capsules, oral, once a day for 15 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Psychiatric Diagnosis of generalized anxiety disorder (GAD) * Outpatients * Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD * Clinical Global Impression (CGI) of Severity Score of at least moderate * Sheehan Disability Scale (SDS) Global Functioning Impairment Score \>= 12 Exclusion Criteria: * Pregnancy or breast feeding * Serious medical illness * Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months * panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year * lifetime history of bipolar or psychosis * Any unstable serious medical condition for which duloxetine would not be allowed * Any use of medications that are not allowed

Locations (7)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beijing, China

Outcomes

Primary Outcomes

Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint

A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Time frame: Baseline, Week 15

Secondary Outcomes

Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint

The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.

Time frame: Baseline, Week 15

Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint

Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).

Time frame: Week 15

Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint

BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.

Time frame: Baseline, Week 15

Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores

Data from ClinicalTrials.gov

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