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An Efficacy and Safety Study 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

Vortioxetine

Placebo

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 - undefined (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, 4th Edition, Text Revision (DSM-IV-TR®) criteria.
Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline.
Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.

Exclusion Criteria:

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 subject 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.
Is taking excluded medications.
Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 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 inhibitors 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 clinically significant unstable illness.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal.
Has a serum creatinine of greater than 1.5 times the upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
Has an abnormal electrocardiogram.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vortioxetine 5 mg

Arm Description

Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.

Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in the Hamilton Anxiety Scale (HAM-A) 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).

Secondary Outcome Measures

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

The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).

Clinical Global Impression Scale-Global Improvement at Week 8

The Clinical Global Impression - Global Improvement scale assesses 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).

Change From Baseline in Sheehan Disability Scale (SDS) Total Score 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).

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

Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (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

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

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

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

Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed

Change From Baseline in Sheehan Disability Scale (SDS) Total Score 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 and P-values were from a mixed model for repeated measurements (MMRM).

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

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 at Each Week Assessed

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).

Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week 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).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Health Care Resource Utilization as 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

NCT00734071

First Posted

August 11, 2008

Last Updated

October 25, 2013

Sponsor

Takeda

Collaborators

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00734071

Brief Title

An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Official Title

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of Single Dose 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

January 2009 (Actual)

Study Completion Date

March 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 treating Generalized Anxiety Disorder.

Detailed Description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine. The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): Vortioxetine 5 mg Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

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

304 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.

Arm Title

Vortioxetine 5 mg

Arm Type

Experimental

Arm Description

Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.

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)

Placebo

Intervention Description

Vortioxetine placebo-matching capsules

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 8

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 8

Title

Clinical Global Impression Scale-Global Improvement at Week 8

Description

Time Frame

Baseline to Week 8

Title

Change From Baseline in Sheehan Disability Scale (SDS) Total Score 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

Baseline and 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

Time Frame

Baseline to Week 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8

Description

Time Frame

Baseline to Week 8

Title

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

Description

Time Frame

Baseline to Weeks 1, 2, 4 and 6.

Title

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

Description

Time Frame

Baseline to Weeks 1 and 4

Title

Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed

Description

Time Frame

Baseline to Weeks 1, 2, 4 and 6

Title

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

Description

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 and P-values were from a mixed model for repeated measurements (MMRM).

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

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 at Each Week Assessed

Description

Time Frame

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

Title

Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed

Description

Time Frame

Baseline to Weeks 1, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed

Description

Time Frame

Baseline to Weeks 2 and 4

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed

Description

The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

Time Frame

Baseline to Weeks 2, 4 and 8

Title

Health Care Resource Utilization as 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

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, 4th Edition, Text Revision (DSM-IV-TR®) criteria. Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline. Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline. Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline. Exclusion Criteria: 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 subject 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. Is taking excluded medications. Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 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 inhibitors 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 clinically significant unstable illness. Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal. Has a serum creatinine of greater than 1.5 times the upper limit of normal. Has a previous history of cancer that had been in remission for less than 5 years. Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator. Has an abnormal electrocardiogram.

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

Arcadia

State/Province

California

Country

United States

City

Irvine

State/Province

California

Country

United States

City

National City

State/Province

California

Country

United States

City

Sherman Oaks

State/Province

California

Country

United States

City

Upland

State/Province

California

Country

United States

City

Washington

State/Province

District of Columbia

Country

United States

City

Bradenton

State/Province

Florida

Country

United States

City

Coral Gables

State/Province

Florida

Country

United States

City

North Miami

State/Province

Florida

Country

United States

City

St Petersburg

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

Oak Brook

State/Province

Illinois

Country

United States

City

Park Ridge

State/Province

Illinois

Country

United States

City

Lafayette

State/Province

Indiana

Country

United States

City

Wichita

State/Province

Kansas

Country

United States

City

Baltimore

State/Province

Maryland

Country

United States

City

Fall River

State/Province

Massachusetts

Country

United States

City

Worcester

State/Province

Massachusetts

Country

United States

City

Flowood

State/Province

Mississippi

Country

United States

City

Bronx

State/Province

New York

Country

United States

City

Brooklyn

State/Province

New York

Country

United States

City

New York

State/Province

New York

Country

United States

City

Morganton

State/Province

North Carolina

Country

United States

City

Cincinnati

State/Province

Ohio

Country

United States

City

Toledo

State/Province

Ohio

Country

United States

City

Oklahoma City

State/Province

Oklahoma

Country

United States

City

Portland

State/Province

Oregon

Country

United States

City

Lincoln

State/Province

Rhode Island

Country

United States

City

Memphis

State/Province

Tennessee

Country

United States

City

Austin

State/Province

Texas

Country

United States

City

San Antonio

State/Province

Texas

Country

United States

City

Charleston

State/Province

West Virginia

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22901736

Citation

Rothschild AJ, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States. Eur Neuropsychopharmacol. 2012 Dec;22(12):858-66. doi: 10.1016/j.euroneuro.2012.07.011. Epub 2012 Aug 15.

Results Reference

result

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An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

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