Trial · NCT02932904

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

NCT02932904, Phase 4, Completed, Takeda; results first posted 2018-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers. Trials, record NCT02932904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02932904

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
NCT number: NCT02932904
Status: Completed
Phases: Phase 4
Enrollment: 361 participants, actual
Lead sponsor: Takeda
Conditions: Healthy Volunteers
Interventions: Vortioxetine, Paroxetine, Placebo
First posted: 2016-10-13
Last updated: 2018-09-14
Results first posted: 2018-09-14

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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)	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.
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)	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.
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)	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.
Secondary	Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4	Baseline and 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.
Secondary	Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5	Baseline and 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.
Secondary	Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5	Baseline and 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.
Secondary	Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5	Weeks 1, 2, 3, 4 and 5	Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women.
Secondary	Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5	Baseline and 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.
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	Baseline and 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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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)	Baseline and Week 5	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4	Baseline and Weeks 1, 2, 3 and 4	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5	Baseline and Weeks 1, 2, 3, 4 and 5	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5	Baseline and Weeks 1, 2, 3, 4 and 5	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5	Weeks 1, 2, 3, 4 and 5	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.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5	Baseline and Weeks 1, 2, 3, 4 and 5	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.	score on a scale	LEAST_SQUARES_MEAN
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	Baseline and Weeks 1, 2, 3, 4 and 5	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.	score on a scale	LEAST_SQUARES_MEAN
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)	Baseline and Week 5	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.	score on a scale	LEAST_SQUARES_MEAN
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)	Baseline and Week 5	mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group235

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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)	Paroxetine 20 mg	Baseline	59.27	Standard Error 0.584	score on a scale
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)	Vortioxetine 10 mg	Baseline	58.56	Standard Error 0.578	score on a scale
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)	Vortioxetine 20 mg	Baseline	59.43	Standard Error 0.560	score on a scale
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)	Paroxetine 20 mg	Change from Baseline at Week 5	-3.56	Standard Error 0.758	score on a scale
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)	Vortioxetine 10 mg	Change from Baseline at Week 5	-0.82	Standard Error 0.752	score on a scale
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)	Vortioxetine 20 mg	Change from Baseline at Week 5	-2.51	Standard Error 0.727	score on a scale
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4	Paroxetine 20 mg	Week 1	-1.67	Standard Error 0.457	score on a scale
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4	Vortioxetine 10 mg	Week 1	-0.54	Standard Error 0.453	score on a scale
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4	Vortioxetine 20 mg	Week 1	-0.38	Standard Error 0.436	score on a scale
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4	Paroxetine 20 mg	Week 2	-2.40	Standard Error 0.617	score on a scale

1 to 10 of 235Source ClinicalTrials.gov

See all 235 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	92
Overall Study	STARTED	Paroxetine 20 mg	85
Overall Study	STARTED	Vortioxetine 10 mg	91
Overall Study	STARTED	Vortioxetine 20 mg	93
Overall Study	Treated	Placebo	91
Overall Study	Treated	Paroxetine 20 mg	84
Overall Study	Treated	Vortioxetine 10 mg	91
Overall Study	Treated	Vortioxetine 20 mg	91
Overall Study	COMPLETED	Placebo	76
Overall Study	COMPLETED	Paroxetine 20 mg	67

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Placebo	4	91
other	Nausea	Gastrointestinal disorders	Paroxetine 20 mg	22	84
other	Nausea	Gastrointestinal disorders	Vortioxetine 10 mg	26	91
other	Nausea	Gastrointestinal disorders	Vortioxetine 20 mg	18	91
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	91
other	Diarrhoea	Gastrointestinal disorders	Paroxetine 20 mg	5	84
other	Diarrhoea	Gastrointestinal disorders	Vortioxetine 10 mg	1	91
other	Diarrhoea	Gastrointestinal disorders	Vortioxetine 20 mg	3	91
other	Fatigue	General disorders	Placebo	2	91
other	Fatigue	General disorders	Paroxetine 20 mg	5	84

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	91
Total, all-cause mortality	Paroxetine 20 mg	0	84
Total, all-cause mortality	Vortioxetine 10 mg	0	91
Total, all-cause mortality	Vortioxetine 20 mg	0	91
Total, other adverse events	Placebo	36	91
Total, other adverse events	Paroxetine 20 mg	59	84
Total, other adverse events	Vortioxetine 10 mg	52	91
Total, other adverse events	Vortioxetine 20 mg	40	91
Total, serious adverse events	Placebo	0	91
Total, serious adverse events	Paroxetine 20 mg	0	84

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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