Generalized Anxiety DisorderPhase 3NCT00730691
Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
A Phase 3 study testing Vortioxetine and Duloxetine in people with Generalized Anxiety Disorder, run by Takeda at 66 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Vortioxetine and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 781 participants
- Where
- 66 sitesUnited States
- Study dates
- Jun 2008to Feb 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a primary diagnosis of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
- Has a Hamilton Anxiety Scale total score ≥ 20. Has a Hamilton Anxiety Scale score ≥2 on both item 1 (anxious mood) and item 2 (tension).
- Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.
Who cannot join
- Had received any investigational compound <30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
- Received Lu AA21004 in a previous clinical study.
- Was a study site employee, or an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
- Has 1 or more of the following:
- Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR® (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
- Current or past history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Show all 29Show fewer
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR® and must have a negative urine drug screen prior to Baseline.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder that might compromise the study.
- Has known sensitivity to duloxetine.
- Is taking excluded medications
- Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
- Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitor and/or serotonin-norepinephrine reuptake inhibitors.
- Has received electroconvulsive therapy within 6 months prior to Screening.
- Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
- Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
- Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level >1.5 times the upper limit of normal.
- Has a serum creatinine level >1.5 upper limit of normal.
- Has a previous history of cancer that had been in remission for less than 5 years.
- Hasclinically significant abnormal vital signs as determined by the investigator.
- Has a history of lack of response to previous adequate treatment with duloxetine for any Generalized Anxiety Disorder episode.
- Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit
- Has a thyroid stimulating hormone value outside the normal range.
- Has an abnormal electrocardiogram.
- has a disease or was taking medications that, in the opinion of the investigator, could have interfered with the assessments of safety, tolerability, or efficacy.
- The patient, in the opinion of the investigator, was unlikely to comply with the clinical study protocol or was unsuitable for any reason.
- Had previously been enrolled in this study.
Trial locations and contacts
66 sites in 1 country.
66 sites in 1 country
United States66 sites
Study site
Albuquerque, New Mexico
Study site
Allentown, Pennsylvania
Study site
Anaheim, California
Study site
Atlanta, Georgia
Study site
Beachwood, Ohio
Study site
Beverly Hills, California
Study site
Brooklyn, New York
Study site
Brown Deer, Wisconsin
Study site
Cedarhurst, New York
Study site
Charlotte, North Carolina
Study site
Chesterfield, Missouri
Study site
Clementon, New Jersey
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Coral Gables, Florida
Study site
Dallas, Texas
Study site
Dayton, Ohio
Study site
Denver, Colorado
Study site
DeSoto, Texas
Study site
Eugene, Oregon
Study site
Farmington, Connecticut
Study site
Fresno, California
Study site
Honolulu, Hawaii
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Lake Jackson, Texas
Study site
Los Angeles, California
Study site
Maitland, Florida
Study site
Media, Pennsylvania
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Middleton, Wisconsin
Study site
Midvale, Utah
Study site
Milwaukee, Wisconsin
Study site
Nashua, New Hampshire
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Norwalk, Connecticut
Study site
Oakbrook Ter, Illinois
Study site
Oceanside, California
Study site
Orlando, Florida
Study site
Owensboro, Kentucky
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Princeton, New Jersey
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Rockville, Maryland
Study site
Roswell, Georgia
Study site
Salem, Oregon
Study site
San Diego, California
Study site
Seattle, Washington
Study site
Sherman Oaks, California
Study site
Shreveport, Louisiana
Study site
Smyrna, Georgia
Study site
St Louis, Missouri
Study site
Staten Island, New York
Study site
Tampa, Florida
Study site
Terre Haute, Indiana
Study site
Toledo, Ohio
Study site
West Palm Beach, Florida
Study site
Wichita Falls, Texas
Study site
Widomar, California
Study site
Winter Park, Florida
Study site
Woodstock, Vermont
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
Read the detailed description
Participants in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.
Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Placebo, Vortioxetine, Duloxetine
- Keywords
- Generalized Anxiety Disorder, Mood Disorder, Affective Disorder, Anxiety Disorder, Drug Therapy
- Medical subject headings
- Generalized Anxiety Disorder, Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo-matching capsules
VortioxetineDrug
Also called Lu AA21004, Brintellix®
Encapsulated vortioxetine immediate release tablets
DuloxetineDrug
Also called Cymbalta
Overencapsulated duloxetine capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo-matching capsules, orally, once daily for up to 9 weeks. Receives: Drug: Placebo |
| Vortioxetine 2.5 mg | Experimental | Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. Receives: Drug: Placebo; Drug: Vortioxetine |
| Vortioxetine 5 mg | Experimental | Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. Receives: Drug: Placebo; Drug: Vortioxetine |
| Vortioxetine 10 mg | Experimental | Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. Receives: Drug: Placebo; Drug: Vortioxetine |
| Duloxetine 60 mg | Active comparator | Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Week 8
Secondary outcomes (15)
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Week 8
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Week 8
Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Week 8
Percentage of Responders in HAM-A Total Score at Week 8
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Measured: Week 8
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Week 8
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Weeks 1, 2, 4 and 6
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Weeks 1 and 4
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Weeks 1, 2, 4 and 6
Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Weeks 1, 2 and 4
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Measured: Baseline and Weeks 1, 2, 4 and 6
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to weeks 1, 2, 4 and 6
Percentage of Participants in HAM-A Remission at Each Week Assessed
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Measured: Weeks 1, 2, 4, 6 and 8
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Weeks 1, 2, 4, 6 and 8
Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.
Measured: Baseline to Weeks 1, 4 and 8
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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 TakedaThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730691
- Sponsor's protocol ID
- LuAA21004_308
- Other IDs
- U1111-1114-3966
- Status last verified
- Oct 2013
- First submitted
- 6 Aug 2008
- Last updated
- 18 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mahableshwarkar AR, Jacobsen PL, Chen Y, Simon JS. A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder. Int J Clin Pract. 2014 Jan;68(1):49-59. doi: 10.1111/ijcp.12328.
PubMed 24341301
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00730691
- Acronym / sponsor ID
- LuAA21004_308
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Mood Disorder, Affective Disorder, Anxiety Disorder, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 18 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
Detailed description
Participants in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.
Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo-matching capsules, orally, once daily for up to 9 weeks. |
| Vortioxetine 2.5 mg | Experimental | Drug: Placebo, Drug: VortioxetineVortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. |
| Vortioxetine 5 mg | Experimental | Drug: Placebo, Drug: VortioxetineVortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. |
| Vortioxetine 10 mg | Experimental | Drug: Placebo, Drug: VortioxetineVortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. |
| Duloxetine 60 mg | Active comparator | Drug: DuloxetineDuloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has a primary diagnosis of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
- Has a Hamilton Anxiety Scale total score ≥ 20. Has a Hamilton Anxiety Scale score ≥2 on both item 1 (anxious mood) and item 2 (tension).
- Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.
Key exclusion criteria (29 listed)
- Had received any investigational compound <30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
- Received Lu AA21004 in a previous clinical study.
- Was a study site employee, or an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
- Has 1 or more of the following:
- Has known sensitivity to duloxetine.
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 |
|---|---|---|
| PlaceboPlacebo-matching capsules | Drug | Placebo, Vortioxetine 10 mg, Vortioxetine 2.5 mg, Vortioxetine 5 mg |
| VortioxetineAlso: Lu AA21004, Brintellix®Encapsulated vortioxetine immediate release tablets | Drug | Vortioxetine 10 mg, Vortioxetine 2.5 mg, Vortioxetine 5 mg |
| DuloxetineAlso: CymbaltaOverencapsulated duloxetine capsules | Drug | Duloxetine 60 mg |
Primary outcome
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8
Time frame: Baseline to Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
15 secondary outcomes
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8
Time frame: Baseline to Week 8
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8
Time frame: Baseline to Week 8
Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
Time frame: Baseline to Week 8
Percentage of Responders in HAM-A Total Score at Week 8
Time frame: Week 8
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
Time frame: Baseline to Week 8
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Time frame: Baseline to Weeks 1, 2, 4 and 6
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed
Time frame: Baseline to Weeks 1 and 4
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
Time frame: Baseline to Weeks 1, 2, 4 and 6
Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed
Time frame: Baseline to Weeks 1, 2 and 4
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Time frame: Baseline and Weeks 1, 2, 4 and 6
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
Time frame: Baseline to weeks 1, 2, 4 and 6
Percentage of Participants in HAM-A Remission at Each Week Assessed
Time frame: Weeks 1, 2, 4, 6 and 8
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Time frame: Baseline to Weeks 1, 2, 4, 6 and 8
Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed
Time frame: Baseline to Weeks 1, 4 and 8
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Time frame: Baseline and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24341301Mahableshwarkar AR, Jacobsen PL, Chen Y, Simon JS. A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder. Int J Clin Pract. 2014 Jan;68(1):49-59. doi: 10.1111/ijcp.12328.
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BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
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.
Medical Director Clinical Science study director
Takeda
66 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 Vortioxetine and Duloxetine in people with Generalized Anxiety Disorder, run by Takeda at 66 sites in United States.
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 3 inclusion and 29 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States. 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 18 Dec 2013). 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 Hamilton Anxiety (HAM-A) Scale Total Score at Week 8 (time frame: Baseline to Week 8). 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 NCT00730691, 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 18 Dec 2013.