Duloxetine Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

Eli Lilly and Company380 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

380

Conditions

Anxiety Disorders

Interventions

Duloxetine HydrochlorideDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (47)

Outcomes

Primary Outcomes

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 Outcomes

Self-reported anxiety symptomatology

Pain

Quality of Life

Clinical Global Improvement and HAMA Factor scores

Maintenance of Effect

Data from ClinicalTrials.gov

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Sherman Oaks, California, United States

Fort Myers, Florida, United States

Atlanta, Georgia, United States

Libertyville, Illinois, United States

Prairie Village, Kansas, United States

Belmont, Massachusetts, United States

Saint Charles, Missouri, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Allentown, Pennsylvania, United States

...and 37 more locations