Duloxetine for the Treatment of Generalized Anxiety Disorder

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

Official Title
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Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br> | Drug: Duloxetine<br>* 60 to 120 mg, capsules, oral, once a day for 15 weeks<br>* Other names: LY248686;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo capsules, oral, once a day for 15 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.' | Baseline, Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | Baseline, Week 15 | 
| Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities. | Baseline, Week 15 | 
| Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). | Baseline, Week 15 | 
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression 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.' | Baseline, Week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety