Anxiety Disorders
Conditions
Brief summary
This is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.
Interventions
DRUGDuloxetine Hydrochloride
DRUGplacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting with generalized anxiety disorder (GAD) in the absence of major depressive disorder (MDD). 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.
Exclusion criteria
* Any current and primary diagnosis other than GAD. Patients diagnosed with or who have a history of 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. * History of alcohol or any psychoactive substance abuse of dependence (as defined in the DSM-IV-TR) within the past 6 months * Serious medical illness, including cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those, that, in the judgement of the investigator, indicate a serious medical problem. * Acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the long-term maintenance of efficacy of duloxetine 60 to 120 mg QD compared with placebo by a comparison of the time to relapse among patients with GAD who responded to duloxetine during the open-label acute therapy phase after 22 to 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported anxiety symptomatology | — |
| Pain | — |
| Quality of Life | — |
| Clinical Global Improvement and HAMA Factor scores | — |
| Maintenance of Effect | — |
Countries
Austria, France, Germany, Netherlands, Portugal, Puerto Rico, United States
Outcome results
None listed