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Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Vortioxetine

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Depressive Disorder, Mood Disorder, Mental Disorder, Melancholia, Involutional, Paraphrenia, Involutional, Drug Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

Has 1 or more the following:
- Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
- 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. (must have 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).
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.
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 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.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
Has a serum creatinine of > 1.5 × 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.
Has an abnormal electrocardiogram.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Vortioxetine 1 mg

Vortioxetine 5 mg

Vortioxetine 10 mg

Placebo

Arm Description

Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.

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

Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.

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

Outcomes

Primary Outcome Measures

Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8

The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Secondary Outcome Measures

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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Percentage of Responders in HAM-D24 Total Score at Week 8

A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.

Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20

The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (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 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Percentage of Participants in MADRS Remission at Week 8

Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.

Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed

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

Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed

The Clinical Global Impression - global improvement 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed

Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20

The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (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 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Percentage of Participants in MADRS Remission at Other Weeks Assessed

Percentage of Participants With a Sustained Response in HAM-D24 Total Score

A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.

Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week

The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

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 participant'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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

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

The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks 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 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Healthcare 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

NCT00735709

First Posted

August 14, 2008

Last Updated

October 25, 2013

Sponsor

Takeda

Collaborators

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00735709

Brief Title

Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Official Title

A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

August 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 effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.

Detailed Description

The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine. The study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 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-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 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

Major Depressive Disorder

Keywords

Depression, Depressive Disorder, Mood Disorder, Mental Disorder, Melancholia, Involutional, Paraphrenia, Involutional, Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

560 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vortioxetine 1 mg

Arm Type

Experimental

Arm Description

Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.

Arm Title

Vortioxetine 5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Vortioxetine 10 mg

Arm Type

Experimental

Arm Description

Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Vortioxetine placebo-matching capsules, 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 immediate-release vortioxetine tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Vortioxetine placebo-matching capsules

Primary Outcome Measure Information:

Title

Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8

Description

Time Frame

Baseline to Week 8

Secondary Outcome Measure Information:

Title

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

Percentage of Responders in HAM-D24 Total Score at Week 8

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20

Description

Time Frame

Baseline to Week 8

Title

Percentage of Participants in MADRS Remission at Week 8

Description

Time Frame

Week 8

Title

Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed

Description

Time Frame

Baseline and Weeks 1, 2, 4 and 6

Title

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

Description

Time Frame

Baseline and Weeks 1, 2 and 6

Title

Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed

Description

Time Frame

Baseline and Weeks 1, 2, 4 and 6

Title

Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed

Description

Time Frame

Baseline and Weeks 1, 2, 4 and 6

Title

Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20

Description

The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (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 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 1, 2, 4 and 6

Title

Percentage of Participants in MADRS Remission at Other Weeks Assessed

Description

Time Frame

Weeks 1, 2, 4 and 6

Title

Percentage of Participants With a Sustained Response in HAM-D24 Total Score

Description

A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.

Time Frame

From Baseline through Week 8

Title

Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline and Weeks 1, 4, and 8

Title

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

Description

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks 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 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2 and 4

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.

Time Frame

Baseline and Weeks 2, 4 and 8

Title

Healthcare 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

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The reported duration of the current major depressive episode is at least 3 months. Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26. A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Exclusion Criteria: Has 1 or more the following: Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR. 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. (must have 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). 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. 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 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. Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal. Has a serum creatinine of > 1.5 × 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. 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

Elizabeth Vale

Country

Australia

City

Southport

Country

Australia

City

Litomerice

Country

Czech Republic

City

Lnare

Country

Czech Republic

City

Prague

Country

Czech Republic

City

Praha

Country

Czech Republic

City

Bully les Mines

Country

France

City

Marseille

Country

France

City

Strasbourg

Country

France

City

Bochum

Country

Germany

City

Chemnitz

Country

Germany

City

Dillingen

Country

Germany

City

Huettenberg

Country

Germany

City

Leipzig

Country

Germany

City

Munchen

Country

Germany

City

München

Country

Germany

City

Nuernberg

Country

Germany

City

Osnabrueck

Country

Germany

City

Rodgau

Country

Germany

City

Westerstede

Country

Germany

City

Bucheon-si

Country

Korea, Republic of

City

Namdong-gu

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Leipaja

Country

Latvia

City

Riga

Country

Latvia

City

Sigulda

Country

Latvia

City

Strenci

Country

Latvia

City

Vilnius

Country

Lithuania

City

Kuala Lumpur

Country

Malaysia

City

Wildervank

Country

Netherlands

City

Białystok

Country

Poland

City

Leszno

Country

Poland

City

Skórzewo

Country

Poland

City

Toruń

Country

Poland

City

Tuszyn

Country

Poland

City

Moscow

Country

Russian Federation

City

Novgorod

Country

Russian Federation

City

St. Petersburg

Country

Russian Federation

City

Stavropol

Country

Russian Federation

City

Tomsk

Country

Russian Federation

City

Durban

Country

South Africa

City

Noordheuwel

Country

South Africa

City

Pretoria

Country

South Africa

City

Lin-Yan District

Country

Taiwan

City

Dnepropetrovsk

Country

Ukraine

City

Kharkiv

Country

Ukraine

City

Lugansk

Country

Ukraine

City

Simferopol

Country

Ukraine

City

Bath

Country

United Kingdom

City

Bolton

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22901346

Citation

Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.

Results Reference

background

PubMed Identifier

27780334

Citation

McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

Results Reference

derived

Learn more about this trial

Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

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