Duloxetine for the Treatment of Generalized Anxiety Disorder

NCT00803361 | Completed Phase 3 Results

• 2 other identifiers: 11517F1J-MC-HMFJ
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Generalized Anxiety Disorder

Keywords

anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint

  Baseline, Week 15

• Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint

  Week 15

• Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint

  Baseline, Week 15

• Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores

  Baseline, Week 15

• Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint

  Baseline, Week 15

Study Arms (2)

Duloxetine

EXPERIMENTAL

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Duloxetine DRUG

60 to 120 mg, capsules, oral, once a day for 15 weeks

Also known as: Cymbalta, LY248686

Duloxetine

Placebo DRUG

placebo capsules, oral, once a day for 15 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Boehringer Ingelheim: collaborator

Study Sites (7)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Beijing, 100088, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Guangzhou, 510370, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Hangzhou, 310009, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Kunming, 650032, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Nanjing, 210029, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Shanghai, 200065, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Xi'an, 710032, China

Location

Related Publications (1)

• Wu WY, Wang G, Ball SG, Desaiah D, Ang QQ. Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China. Chin Med J (Engl). 2011 Oct;124(20):3260-8.

  PMID: 22088518 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time(UTC/GMT -5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 5, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 17, 2010
• Results First Posted: December 17, 2010

Record last verified: 2010-11

Locations

CN (7)