Clinical Trials Logo
  1. Home
  2. Anxiety Disorders
  3. NCT00122824
  4. Details
NCT00122824 Clinical Trial

Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

Anxiety Disorders Clinical Trial

Official title:
Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00122824
Other study ID # 5075
Secondary ID F1J-MC-HMBR
Status Completed
Phase Phase 3
First received July 20, 2005
Last updated November 5, 2007
Start date June 2004
Est. completion date September 2005

Study information
Verified date November 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

Recruitment information / eligibility
Status Completed
Enrollment 480
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male and female outpatients at least 18 years of age

Exclusion Criteria:

- Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine

- Patient diagnosed with major depressive disorder within the past 6 months

- Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year

- History of alcohol or any psychoactive substance abuse or dependence within the past 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• duloxetine hydrochloride

• placebo

Locations
Country Name City State
Finland For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Oulu
France For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Bourg-en-Bresse
Germany For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Berlin
South Africa For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Paarl
Spain For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Barcelona
Sweden For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Uppsala
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) or 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. Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Finland,  France,  Germany,  South Africa,  Spain,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score.
Secondary Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores
See also
  Status Clinical Trial Phase
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Active, not recruiting NCT04136054 - Better Sleep in Psychiatric Care - Anxiety and Affective Disorders N/A
Completed NCT04091139 - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong Phase 2/Phase 3
Completed NCT04647318 - Physiological Response to Self-compassion Versus Relaxation N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Completed NCT05078450 - Mood Lifters Online for Graduate Students and Young Professionals N/A
Not yet recruiting NCT06162624 - Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons N/A
Not yet recruiting NCT05747131 - Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children N/A
Not yet recruiting NCT05863637 - Intensive Short-Term Dynamic Psychotherapy (ISTDP) for Anxiety Diagnoses in a Primary Care Setting N/A
Not yet recruiting NCT05225701 - Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders. N/A
Completed NCT02579915 - Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC) N/A
Recruiting NCT02186366 - Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type N/A
Recruiting NCT02376959 - Effect of Spiritist "Passe" Energy Therapy in Reducing Anxiety in Volunteers N/A
Not yet recruiting NCT02126787 - Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment N/A
Withdrawn NCT01953042 - Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders N/A
Completed NCT02134730 - School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial N/A
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3

External Links