Clinical trial NCT00803361: Duloxetine for the Treatment of Generalized Anxiety Disorder
Official title: Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: anxiety
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2008-12-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
timeFrame: Baseline, Week 15
Secondary outcomes:
measure: Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
timeFrame: Baseline, Week 15
measure: Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
timeFrame: Week 15
measure: Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
timeFrame: Baseline, Week 15
measure: Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
timeFrame: Baseline, Week 15
measure: Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
timeFrame: Baseline, Week 15
measure: Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
timeFrame: Baseline, Week 15
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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.
city: Guang Zhou
country: China
facility: 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.
city: Hangzhou
country: China
facility: 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.
city: Kunming
country: China
facility: 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.
city: Nanjing
country: China
facility: 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.
city: Shanghai
country: China
facility: 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.
city: Xi'An
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time(UTC/GMT -5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Wu WY, Wang G, Ball SG, Desaiah D, Ang QQ. Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China. Chin Med J (Engl). 2011 Oct;124(20):3260-8.