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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1174-1779 | Other Identifier | WHO |
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The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.
The drug being tested in this study is called vortioxetine. This study will look at the effect of treatment on sexual functioning in healthy participants.
The study will enroll approximately 352 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.
This multicenter trial will be conducted in United States. The overall time to participate in this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 10 mg | Experimental | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
|
| Vortioxetine 20 mg | Experimental | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
|
| Paroxetine 20 mg | Active Comparator | Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
|
| Placebo | Placebo Comparator | Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Vortioxetine Overencapsulated Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | Baseline and Week 5 |
| Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | Baseline and Week 5 |
| Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encino | California | United States | ||||
Healthy volunteers were randomized in a 1:1:1:1 ratio to one of 4 treatment arms: vortioxetine 10 mg, vortioxetine 20 mg, paroxetine or placebo.
Participants took part in the study at 16 investigative sites in the United States from 21 November 2016 to 09 June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. |
| FG001 | Paroxetine 20 mg | Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2017 | May 22, 2018 |
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| Paroxetine | Drug | Paroxetine Overencapsulated Tablets. |
|
| Placebo | Drug | Vortioxetine Placebo-matching Capsules. |
|
| Baseline and Week 5 |
| Baseline and Weeks 1, 2, 3 and 4 |
| Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | Baseline and Weeks 1, 2, 3, 4 and 5 |
| Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | Baseline and Weeks 1, 2, 3, 4 and 5 |
| Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women. | Weeks 1, 2, 3, 4 and 5 |
| Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | Baseline and Weeks 1, 2, 3, 4 and 5 |
| Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | Baseline and Weeks 1, 2, 3, 4 and 5 |
| Long Beach |
| California |
| United States |
| Torrance | California | United States |
| Jacksonville | Florida | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Decatur | Georgia | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Portland | Oregon | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Charlottesville | Virginia | United States |
| Seattle | Washington | United States |
| FG002 | Vortioxetine 10 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
| FG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. |
| BG001 | Paroxetine 20 mg | Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
| BG002 | Vortioxetine 10 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
| BG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All randomized participants. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Median Age Categories | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Race Categories | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Height | All randomized participants. | Mean | Standard Deviation | cm |
| |||||||||
| Weight | All randomized participants. | Mean | Standard Deviation | kg |
| |||||||||
| Body Mass Index (BMI) | Body Mass Index = weight (kg)/[height (m)^2] | All randomized participants. | Mean | Standard Deviation | kg/m^2 |
| ||||||||
| Smoking Classification | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Female Reproductive Status | All randomized participants. | Count of Participants | Participants |
| ||||||||||
| Duration of Menstruation | All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline. | Mean | Standard Deviation | days |
| |||||||||
| Duration of Menstrual Cycle | All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline. | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 5 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1, 2, 3 and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1, 2, 3, 4 and 5 |
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| Secondary | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1, 2, 3, 4 and 5 |
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| Secondary | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure. | Posted | Number | percentage of participants | Weeks 1, 2, 3, 4 and 5 |
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| Secondary | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1, 2, 3, 4 and 5 |
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| Secondary | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1, 2, 3, 4 and 5 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | mFAS1 included all participants in the FAS except those who had active drug concentrations below the limit of quantification (BLOQ) at all study visits where pharmacokinetic (PK) samples were collected. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 5 |
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| Primary | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. | mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 5 |
|
From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. | 0 | 91 | 0 | 91 | 36 | 91 |
| EG001 | Paroxetine 20 mg | Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. | 0 | 84 | 0 | 84 | 59 | 84 |
| EG002 | Vortioxetine 10 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. | 0 | 91 | 0 | 91 | 52 | 91 |
| EG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. | 0 | 91 | 0 | 91 | 40 | 91 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Orgasm abnormal | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA Version 20.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2017 | May 22, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
Not provided
Not provided
|
|
|
| Non-Hispanic and Latino |
|
|
|
| Asian |
|
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| Black or African American |
|
|
| Native Hawaiian or Other Pacific Islander |
|
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| White |
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| Multiracial |
|
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| > 28 Years |
|
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| Non-white |
|
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|
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| Participant is a current smoker |
|
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| Participant is an ex-smoker |
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| Female of childbearing potential |
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| NA/Participant is male |
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| ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate. | ANCOVA with LOCF | 0.303 | The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05. | LS Mean Difference | 1.05 | Standard Error of the Mean | 1.017 | 2-Sided | 95 | -0.95 | 3.05 | Superiority |
| OG002 | Vortioxetine 20 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 |
| Vortioxetine 20 mg |
Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
|
|
|
|
|
|
Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
| OG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
|
|
Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. |
| OG003 | Vortioxetine 20 mg | Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
|
|
| Vortioxetine 20 mg |
Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
|
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Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. |
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