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

Study Overview
=================
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.

Official Title
-----------------
Duloxetine 60 to 120 mg Once Daily Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|nan|
|Drug: placebo|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety symptomatology |  |  | 
| Pain |  |  | 
| Quality of Life |  |  | 
| Clinical Global Improvement and HAMA Factor scores |  |  | 
| Maintenance of Effect |  |  |