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Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

Vortioxetine

Duloxetine

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, Mood Disorder, Affective Disorder, Anxiety Disorder, Drug Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
- 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

Vortioxetine 2.5 mg

Vortioxetine 5 mg

Vortioxetine 10 mg

Duloxetine 60 mg

Arm Description

Placebo-matching capsules, orally, once daily for up to 9 weeks.

Vortioxetine 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 encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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).

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.

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.

Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed

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.

Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed

Percentage of Responders in HAM-A Total Score at Other Weeks Assessed

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.

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).

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.

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.

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.

Full Information

NCT ID

NCT00730691

First Posted

August 6, 2008

Last Updated

October 25, 2013

Sponsor

Takeda

Collaborators

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00730691

Brief Title

Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

Collaborators

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder, Mood Disorder, Affective Disorder, Anxiety Disorder, Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

781 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo-matching capsules, orally, once daily for up to 9 weeks.

Arm Title

Vortioxetine 2.5 mg

Arm Type

Experimental

Arm Description

Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Arm Title

Vortioxetine 5 mg

Arm Type

Experimental

Arm Description

Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Arm Title

Vortioxetine 10 mg

Arm Type

Experimental

Arm Description

Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.

Arm Title

Duloxetine 60 mg

Arm Type

Active Comparator

Arm Description

Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo-matching capsules

Intervention Type

Drug

Intervention Name(s)

Vortioxetine

Other Intervention Name(s)

Lu AA21004, Brintellix®

Intervention Description

Encapsulated vortioxetine immediate release tablets

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Overencapsulated duloxetine capsules

Primary Outcome Measure Information:

Title

Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8

Description

Time Frame

Baseline to Week 8

Secondary Outcome Measure Information:

Title

Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8

Description

Time Frame

Baseline to Week 8

Title

Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8

Description

Time Frame

Baseline to Week 8

Title

Change From Baseline in Sheehan Disability Scale (SDS) at Week 8

Description

Time Frame

Baseline to Week 8

Title

Percentage of Responders in HAM-A Total Score at Week 8

Description

Time Frame

Week 8

Title

Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25

Description

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.

Time Frame

Baseline to Week 8

Title

Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed

Description

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.

Time Frame

Baseline to Weeks 1, 2, 4 and 6

Title

Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed

Description

Time Frame

Baseline to Weeks 1 and 4

Title

Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed

Description

Time Frame

Baseline to Weeks 1, 2, 4 and 6

Title

Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed

Description

Time Frame

Baseline to Weeks 1, 2 and 4

Title

Percentage of Responders in HAM-A Total Score at Other Weeks Assessed

Description

Time Frame

Baseline and Weeks 1, 2, 4 and 6

Title

Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25

Description

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.

Time Frame

Baseline to weeks 1, 2, 4 and 6

Title

Percentage of Participants in HAM-A Remission at Each Week Assessed

Description

Time Frame

Weeks 1, 2, 4, 6 and 8

Title

Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)

Description

Time Frame

Baseline to Weeks 1, 2, 4, 6 and 8

Title

Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed

Description

Time Frame

Baseline to Weeks 1, 4 and 8

Title

Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire

Description

Time Frame

Baseline and Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director Clinical Science

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Anaheim

State/Province

California

Country

United States

City

Beverly Hills

State/Province

California

Country

United States

City

Fresno

State/Province

California

Country

United States

City

Los Angeles

State/Province

California

Country

United States

City

Oceanside

State/Province

California

Country

United States

City

San Diego

State/Province

California

Country

United States

City

Sherman Oaks

State/Province

California

Country

United States

City

Widomar

State/Province

California

Country

United States

City

Denver

State/Province

Colorado

Country

United States

City

Farmington

State/Province

Connecticut

Country

United States

City

Norwalk

State/Province

Connecticut

Country

United States

City

Coral Gables

State/Province

Florida

Country

United States

City

Jacksonville

State/Province

Florida

Country

United States

City

Maitland

State/Province

Florida

Country

United States

City

Miami

State/Province

Florida

Country

United States

City

Orlando

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

West Palm Beach

State/Province

Florida

Country

United States

City

Winter Park

State/Province

Florida

Country

United States

City

Atlanta

State/Province

Georgia

Country

United States

City

Roswell

State/Province

Georgia

Country

United States

City

Smyrna

State/Province

Georgia

Country

United States

City

Honolulu

State/Province

Hawaii

Country

United States

City

Oakbrook Ter

State/Province

Illinois

Country

United States

City

Terre Haute

State/Province

Indiana

Country

United States

City

Owensboro

State/Province

Kentucky

Country

United States

City

Shreveport

State/Province

Louisiana

Country

United States

City

Rockville

State/Province

Maryland

Country

United States

City

Chesterfield

State/Province

Missouri

Country

United States

City

St Louis

State/Province

Missouri

Country

United States

City

Nashua

State/Province

New Hampshire

Country

United States

City

Clementon

State/Province

New Jersey

Country

United States

City

Princeton

State/Province

New Jersey

Country

United States

City

Albuquerque

State/Province

New Mexico

Country

United States

City

Brooklyn

State/Province

New York

Country

United States

City

Cedarhurst

State/Province

New York

Country

United States

City

New York

State/Province

New York

Country

United States

City

Rochester

State/Province

New York

Country

United States

City

Staten Island

State/Province

New York

Country

United States

City

Charlotte

State/Province

North Carolina

Country

United States

City

Raleigh

State/Province

North Carolina

Country

United States

City

Beachwood

State/Province

Ohio

Country

United States

City

Cleveland

State/Province

Ohio

Country

United States

City

Dayton

State/Province

Ohio

Country

United States

City

Toledo

State/Province

Ohio

Country

United States

City

Eugene

State/Province

Oregon

Country

United States

City

Portland

State/Province

Oregon

Country

United States

City

Salem

State/Province

Oregon

Country

United States

City

Allentown

State/Province

Pennsylvania

Country

United States

City

Media

State/Province

Pennsylvania

Country

United States

City

Philadelphia

State/Province

Pennsylvania

Country

United States

City

Columbia

State/Province

South Carolina

Country

United States

City

Memphis

State/Province

Tennessee

Country

United States

City

Nashville

State/Province

Tennessee

Country

United States

City

Dallas

State/Province

Texas

Country

United States

City

DeSoto

State/Province

Texas

Country

United States

City

Houston

State/Province

Texas

Country

United States

City

Lake Jackson

State/Province

Texas

Country

United States

City

Wichita Falls

State/Province

Texas

Country

United States

City

Midvale

State/Province

Utah

Country

United States

City

Woodstock

State/Province

Vermont

Country

United States

City

Richmond

State/Province

Virginia

Country

United States

City

Seattle

State/Province

Washington

Country

United States

City

Brown Deer

State/Province

Wisconsin

Country

United States

City

Middleton

State/Province

Wisconsin

Country

United States

City

Milwaukee

State/Province

Wisconsin

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24341301

Citation

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.

Results Reference

derived

Learn more about this trial

Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

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