Trial Outcomes & Findings for Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder (NCT NCT02972632)

Last Updated: 2019-07-11

Results Overview

GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at the outset of study. Another evaluation took place at end of study (EOS) visit to determine the level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with a standard deviation (SD) of 10. Higher score indicates composite of 3 goals (50 or above) as response.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

123 participants

Primary outcome timeframe

Week 12

Results posted on

2019-07-11

Participant Flow

Participants took part in the study at 23 investigative sites in United States from 22 December 2016 to 06 February 2018.

Participants with a diagnosis of major depressive disorder were enrolled to receive vortioxetine with a starting dose of 10 mg for 12 weeks. Dose was increased or decreased as per investigator's discretion.

Participant milestones

Participant milestones
Measure	Vortioxetine Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Overall Study STARTED	123
Overall Study Safety Analysis Set	122
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Vortioxetine Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Overall Study Pretreatment Event/Adverse Event	3
Overall Study Lost to Follow-up	4
Overall Study Voluntary Withdrawal	10

Baseline Characteristics

Goal Achievement After a Change to Vortioxetine in Adults With Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vortioxetine n=122 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Age, Continuous	45.3 years STANDARD_DEVIATION 12.22 • n=5 Participants
Age, Customized <= 55 Years	95 Participants n=5 Participants
Age, Customized > 55 Years	27 Participants n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	28 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	94 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	28 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White	83 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants
Region of Enrollment United States	122 Participants n=5 Participants
Height	164.5 cm STANDARD_DEVIATION 10.43 • n=5 Participants
Weight	91.59 kg STANDARD_DEVIATION 23.118 • n=5 Participants
Body Mass Index (BMI)	34.13 kg/m^2 STANDARD_DEVIATION 9.666 • n=5 Participants
Smoking Classification Never smoked	75 Participants n=5 Participants
Smoking Classification Current smoker	23 Participants n=5 Participants
Smoking Classification Ex-smoker	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full analysis set (FAS) included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Outcome measures
Measure	Vortioxetine n=109 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12	57.8 percentage of participants Interval 48.5 to 67.1

SECONDARY outcome

Timeframe: Baseline and Weeks 6 and 12

Population: FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.

GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at outset of study. Another evaluation took place at EOS visit to determine level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with SD of 10. The total score ranges between 22.6 and 77.4. A positive change from baseline in the composite of 3 goals (50 or above) indicates response.

Outcome measures

Outcome measures
Measure	Vortioxetine n=116 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12 Baseline	23.57 score on a scale Standard Deviation 0.073
Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12 Change at Week 6	18.21 score on a scale Standard Deviation 11.470
Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12 Change at Week 12	26.94 score on a scale Standard Deviation 13.582

SECONDARY outcome

Timeframe: Baseline and Weeks 6 and 12

PHQ-9 is a well-established participant reported outcome tool for assessment of change in depressive symptoms and is a sensitive measure of depression severity. The PHQ-9 consists of a 9-item scale originally developed for primary care settings, with 1 item corresponding to each of the 9 made symptom criteria for depression in diagnostic and statistical manual of mental disorders (DSM), asking if they have bothered the participant over the last 2 weeks. Each question is rated on a scale from 0 (not at all) to 3 (nearly every day). If any problems are answered 1 or higher, a final question on how difficult those problems made it to do work, take care of things at home, or get along with other people is completed, rated from not difficult at all to extremely difficult. The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity. A positive change from baseline indicates severe condition.

Outcome measures

Outcome measures
Measure	Vortioxetine n=116 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12 Baseline	15.7 score on a scale Standard Deviation 4.79
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12 Change at Week 6	-6.5 score on a scale Standard Deviation 6.15
Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12 Change at Week 12	-8.4 score on a scale Standard Deviation 6.22

SECONDARY outcome

Timeframe: Baseline and Weeks 6 and 12

The PDQ-D is a 20-item, patient-reported questionnaire with a 7-day recall period. Scores for four subscales. All 20 items use the same 5-point ordinal categorical response scale to reflect the frequency of experiencing a specific cognitive problem in the past 7 days. Scores for each of the four measured subscales are calculated by assigning a value of 0 ("never in the past 7 days"), 1 ("rarely - once or twice"), 2 ("sometimes - 3-5 times"), 3 ("often - about once a day"), or 4 ("very often - more than once a day") to each item, then summing the five items of that subscale, to produce a score ranging from 0 to 20. A total global score for overall cognitive dysfunction (range 0-80) is calculated by summing the four subscale scores. Higher scores for each subscale and for the total score indicate greater perceived cognitive dysfunction. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Vortioxetine n=116 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12 Baseline	40.5 score on a scale Standard Deviation 14.87
Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12 Change at Week 6	-14.8 score on a scale Standard Deviation 13.70
Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12 Change at Week 12	-18.0 score on a scale Standard Deviation 16.92

SECONDARY outcome

Timeframe: Baseline and Week 12

Q-LES-Q is a scale designed to allow researchers to assess the degree of a participant's quality of life in various areas of daily living. There is not a "Total Score" per se for the Q-LES-Q. The scale is divided into domains. Ninety-one of the 93 items are assembled into 8 categories: physical health/activities, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. Items are scored on a 5 point scale, from 1 (not at all or never) to 5 (frequently or all the time), to indicate the degree of enjoyment or satisfaction experienced by domain. Raw summary scores are expressed as a percentage of the maximum possible score within a given domain to facilitate comparisons across areas of functioning. The total score is based on the Overall Life Satisfaction question in General Activities and ranges from 1 to 5. A positive change from baseline indicates greater enjoyment/satisfaction.

Outcome measures

Outcome measures
Measure	Vortioxetine n=116 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12 Baseline	2.487 score on a scale Standard Deviation 0.8822
Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12 Change at Week 12	1.128 score on a scale Standard Deviation 1.1871

SECONDARY outcome

Timeframe: Baseline and Week 12

WHO-5 is a short, self-administered questionnaire covering 5 positively worded items, related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things). Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25, with higher score meaning better well-being. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Vortioxetine n=116 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12 Baseline	5.6 score on a scale Standard Deviation 3.48
Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12 Change at Week 12	7.2 score on a scale Standard Deviation 6.59

SECONDARY outcome

Timeframe: Baseline and Week 12

CGI-S is a clinician rated scale designed to assess global severity of illness and change in the clinical condition over time. The CGI-S provides the clinician's impression of the participant's state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's mental illness on a 7-point scale ranging from 1 (normal-not at all ill) to 7 (among the most extremely ill participants). Higher scores indicate greater severity of illness. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Vortioxetine n=116 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12 Baseline	4.4 score on a scale Standard Deviation 0.50
Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12 Change at Week 12	-1.6 score on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

CGI-I assesses the participant's improvement (or worsening). The clinician assessed participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicated greater severity of illness.

Outcome measures

Outcome measures
Measure	Vortioxetine n=111 Participants Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12	2.2 score on a scale Standard Deviation 1.05

Adverse Events

Vortioxetine

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vortioxetine n=122 participants at risk Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Psychiatric disorders Depression	0.82% 1/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Suicidal Ideation	0.82% 1/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Vortioxetine n=122 participants at risk Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.
Gastrointestinal disorders Nausea	21.3% 26/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Constipation	5.7% 7/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	5.7% 7/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Headache	9.0% 11/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Anxiety	6.6% 8/122 • Baseline up to Day 113 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all participants who were enrolled and received at least one dose of study drug.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER