Healthy VolunteersPhase 4NCT02932904

Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers

A Phase 4 study testing Vortioxetine and Paroxetine in people with Healthy Volunteers, run by Takeda at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Vortioxetine and Paroxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 361 participants
Where: 15 sitesUnited States
Study dates: 21 Nov 2016to 9 Jun 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Who cannot join

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a history of depression or any other psychiatric illness.

Show all 12Show fewer

Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
If female, has polycystic ovarian syndrome.
Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Charlottesville, Virginia
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Encino, California
Study site
Jacksonville, Florida
Study site
Las Vegas, Nevada
Study site
Long Beach, California
Study site
Orlando, Florida
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Torrance, California

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Placebo- and Active-Controlled, Phase 4 Study Evaluating the Effect of Vortioxetine 10 and 20 mg/Day vs Paroxetine 20 mg/Day on Sexual Functioning in Healthy Subjects

Read the detailed description

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):

Vortioxetine 10 mg
Vortioxetine 20 mg
Paroxetine 20 mg
Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

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.

Conditions: Healthy Volunteers
Being tested: Vortioxetine, Paroxetine, Placebo
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VortioxetineDrug
Vortioxetine Overencapsulated Tablet
ParoxetineDrug
Paroxetine Overencapsulated Tablets.
PlaceboDrug
Vortioxetine Placebo-matching Capsules.

Study groups in NCT02932904
Study group	Role	What they receive
Vortioxetine 10 mg	Experimental	Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. Receives: Drug: Vortioxetine
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. Receives: Drug: Vortioxetine
Paroxetine 20 mg	Active comparator	Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. Receives: Drug: Paroxetine
Placebo	Placebo comparator	Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 5

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Weeks 1, 2, 3, 4 and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 20169 Jun 2017

First posted13 Oct 2016 (estimated)
Study start21 Nov 2016
Primary completion31 May 2017
Study completion9 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02932904
Sponsor's protocol ID: Vortioxetine-4001
Other IDs: U1111-1174-1779
Status last verified: Aug 2018
First submitted: 12 Oct 2016
Last updated: 14 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel Group, Placebo- and Active-Controlled, Phase 4 Study Evaluating the Effect of Vortioxetine 10 and 20 mg/Day vs Paroxetine 20 mg/Day on Sexual Functioning in Healthy Subjects
ClinicalTrials.gov ID: NCT02932904
Acronym / sponsor ID: Vortioxetine-4001
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 21 Nov 2016 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 9 Jun 2017 (actual)
First posted: 13 Oct 2016 (estimated)
Results: Posted 14 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Vortioxetine 10 mg
Vortioxetine 20 mg
Paroxetine 20 mg
Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vortioxetine 10 mg	Experimental	Drug: VortioxetineVortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
Vortioxetine 20 mg	Experimental	Drug: VortioxetineVortioxetine 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	Drug: ParoxetineParoxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
Placebo	Placebo comparator	Drug: PlaceboVortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Key exclusion criteria (12 listed)

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VortioxetineVortioxetine Overencapsulated Tablet	Drug	Vortioxetine 10 mg, Vortioxetine 20 mg
ParoxetineParoxetine Overencapsulated Tablets.	Drug	Paroxetine 20 mg
PlaceboVortioxetine Placebo-matching Capsules.	Drug	Placebo

Primary outcome

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)
Time frame: Baseline and Week 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.
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)
Time frame: Baseline and Week 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.
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)
Time frame: Baseline and Week 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.

6 secondary outcomes

Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 1, 2, 3, 4 and 5
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5
Time frame: 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
Time frame: Baseline and Weeks 1, 2, 3, 4 and 5

Results and safety

Results posted to the registry on 14 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	92	76
Paroxetine 20 mg	85	67
Vortioxetine 10 mg	91	68
Vortioxetine 20 mg	93	79

Primary outcome: 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)

Time frame: Baseline and Week 5. Least squares mean (Standard Error). Unit: score on a scale

Measure	Paroxetine 20 mg n = 83	Vortioxetine 10 mg n = 85	Vortioxetine 20 mg n = 91
Baseline	59.27 (0.584)	58.56 (0.578)	59.43 (0.560)
Change from Baseline at Week 5	-3.56 (0.758)	-0.82 (0.752)	-2.51 (0.727)

Paroxetine 20 mg vs Vortioxetine 10 mg: Least square (LS) Mean Difference: 2.74 (95% CI 0.69 to 4.78), p = 0.009, ANCOVA with LOCF
Paroxetine 20 mg vs Vortioxetine 20 mg: LS Mean Difference: 1.05 (95% CI -0.95 to 3.05), p = 0.303, ANCOVA with LOCF

Population analysed: 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.

Primary outcome: Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)

Time frame: Baseline and Week 5. Least squares mean (Standard Error). Unit: score on a scale

Measure	Paroxetine 20 mg n = 74	Vortioxetine 10 mg n = 82	Vortioxetine 20 mg n = 84
Baseline	59.13 (0.614)	58.55 (0.582)	59.36 (0.576)
Change from Baseline at Week 5	-4.01 (0.803)	-0.63 (0.763)	-2.38 (0.754)

Paroxetine 20 mg vs Vortioxetine 10 mg: LS Mean Difference: 3.38 (95% CI 1.25 to 5.51), p = 0.002, ANCOVA with LOCF
Paroxetine 20 mg vs Vortioxetine 20 mg: LS Mean Difference: 1.63 (95% CI -0.47 to 3.73), p = 0.129, ANCOVA with LOCF

Population analysed: 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.

Primary outcome: Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)

Time frame: Baseline and Week 5. Least squares mean (Standard Error). Unit: score on a scale

Measure	Paroxetine 20 mg n = 60	Vortioxetine 10 mg n = 79	Vortioxetine 20 mg n = 79
Baseline	58.73 (0.675)	58.53 (0.589)	59.23 (0.591)
Change from Baseline at Week 5	-4.78 (0.828)	-0.47 (0.724)	-1.72 (0.724)

Paroxetine 20 mg vs Vortioxetine 10 mg: LS Mean Difference: 4.31 (95% CI 2.19 to 6.43), p <0.001, ANCOVA with LOCF
Paroxetine 20 mg vs Vortioxetine 20 mg: LS Mean Difference: 3.06 (95% CI 0.95 to 5.17), p = 0.005, ANCOVA with LOCF

Population analysed: mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 91 (0%)	36 of 91 (39.6%)	0 of 91
Paroxetine 20 mg	0 of 84 (0%)	59 of 84 (70.2%)	0 of 84
Vortioxetine 10 mg	0 of 91 (0%)	52 of 91 (57.1%)	0 of 91
Vortioxetine 20 mg	0 of 91 (0%)	40 of 91 (44%)	0 of 91

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vortioxetine and Paroxetine in people with Healthy Volunteers, run by Takeda at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline and Week 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.