Generalized Anxiety DisorderPhase 3NCT00803361
Duloxetine for the Treatment of Generalized Anxiety Disorder
A Phase 3 study testing Duloxetine in people with Generalized Anxiety Disorder, run by Eli Lilly and Company at 7 sites in China.
Trial summary
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 7 sitesChina
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
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
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
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
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
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
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
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
About this study
Official title: Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Duloxetine, Placebo
- Keywords
- anxiety
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta, LY248686
60 to 120 mg, capsules, oral, once a day for 15 weeks
PlaceboDrug
placebo capsules, oral, once a day for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Not described Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.'
Measured: Baseline, Week 15
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.'
Measured: Baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803361
- Sponsor's protocol ID
- 11517
- Other IDs
- F1J-MC-HMFJ
- Status last verified
- Nov 2010
- First submitted
- 3 Dec 2008
- Last updated
- 17 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22088518
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China
- ClinicalTrials.gov ID
- NCT00803361
- Acronym / sponsor ID
- 11517
- Conditions
- Generalized Anxiety Disorder
- Keywords
- anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 17 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: Duloxetine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: Cymbalta, LY24868660 to 120 mg, capsules, oral, once a day for 15 weeks | Drug | Duloxetine |
| Placeboplacebo capsules, oral, once a day for 15 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Time frame: Baseline, Week 15
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.'
6 secondary outcomes
Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
Time frame: Baseline, Week 15
Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
Time frame: Week 15
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Time frame: Baseline, Week 15
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Time frame: Baseline, Week 15
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Time frame: Baseline, Week 15
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
Time frame: Baseline, Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22088518Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Generalized Anxiety Disorder, run by Eli Lilly and Company at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint (time frame: Baseline, Week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.