HealthyPhase 1NCT02097147
Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo
A Phase 1 study testing Vilazodone 20 mg, Vilazodone 40 mg and Paroxetine 20 mg in people with Healthy, run by Forest Laboratories at 4 sites in United States.
Trial summary
To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vilazodone 20 mg, Vilazodone 40 mg and Paroxetine 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, aged 18 through 45 years, inclusive
- Currently sexually active
- If female, non pregnant and agree to use acceptable for of contraception during
- If male, be sterile or have partner use contraception.
Who cannot join
- Have sexual dysfunction
- Have history of diagnosis or treatment of any disorder related to sexual functioning.
- Clinically significant disease state, in the opinion of the examining physician, in any body system
- History of alcohol or other substance abuse or dependence within the previous 5 years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Forest Investigative Site 004
Charlottesville, Virginia, 22903
Forest Investigative Site 001
Miami, Florida, 33014
Forest Investigative Site 002
Overland Park, Kansas, 66212
Forest Investigative Site 003
Saint Paul, Minnesota, 55114
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo
To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.
- Conditions
- Healthy
- Being tested
- Vilazodone 20 mg, Vilazodone 40 mg, Paroxetine 20 mg, Placebo
- Keywords
- Viibryd
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilazodone 20 mgDrug
Also called Viibyrd
Oral administration, once per day.
Vilazodone 40 mgDrug
Also called Viibryd
Oral administration, once per day.
Paroxetine 20 mgDrug
Also called Paxil
Oral administration, once per day.
PlaceboDrug
Oral administration, once per day.
| Study group | Role | What they receive |
|---|---|---|
| Vilazodone 20 mg | Experimental | Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days. Receives: Drug: Vilazodone 20 mg |
| Vilazodone 40 mg | Experimental | Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 7 days, followed by vilazodone 40 mg once daily for 21 days Receives: Drug: Vilazodone 40 mg |
| Paroxetine 20 mg | Active comparator | Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days Receives: Drug: Paroxetine 20 mg |
| Placebo | Placebo comparator | Placebo once daily for 35 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score
The CSFQ is a subject-rated scale designed to measure changes in sexual function and is a structured, self-report, 14-item questionnaire, that measures sexual functioning as a total score (all 14 items), and on the subscales of pleasure, desire/frequency, desire/interest, arousal, and orgasm, rated on a 5 point scale, with each item rated from 1 to 5, and a total score range of 14 to 70. Lower scores are associated with worsened sexual functioning.
Measured: From Baseline to Day 35
Secondary outcomes (1)
Proportion of subjects meeting criteria for sexual dysfunction.
Proportion of subjects meeting criteria for sexual dysfunction (ie, CSFQ <=47 for males and <=41 for females) at any 2 consecutive visits during the double-blind treatment period.
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maju Mathews, MD, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097147
- Sponsor's protocol ID
- VLZ-MD-24
- Status last verified
- Feb 2015
- First submitted
- 24 Mar 2014
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo
- ClinicalTrials.gov ID
- NCT02097147
- Acronym / sponsor ID
- VLZ-MD-24
- Conditions
- Healthy
- Keywords
- Viibryd
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vilazodone 20 mg | Experimental | Drug: Vilazodone 20 mgVilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days. |
| Vilazodone 40 mg | Experimental | Drug: Vilazodone 40 mgVilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 7 days, followed by vilazodone 40 mg once daily for 21 days |
| Paroxetine 20 mg | Active comparator | Drug: Paroxetine 20 mgParoxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily for 35 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female, aged 18 through 45 years, inclusive
- Currently sexually active
- If female, non pregnant and agree to use acceptable for of contraception during
- If male, be sterile or have partner use contraception.
Key exclusion criteria (4 listed)
- Have sexual dysfunction
- Have history of diagnosis or treatment of any disorder related to sexual functioning.
- Clinically significant disease state, in the opinion of the examining physician, in any body system
- History of alcohol or other substance abuse or dependence within the previous 5 years
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 |
|---|---|---|
| Vilazodone 20 mgAlso: ViibyrdOral administration, once per day. | Drug | Vilazodone 20 mg |
| Vilazodone 40 mgAlso: ViibrydOral administration, once per day. | Drug | Vilazodone 40 mg |
| Paroxetine 20 mgAlso: PaxilOral administration, once per day. | Drug | Paroxetine 20 mg |
| PlaceboOral administration, once per day. | Drug | Placebo |
Primary outcome
Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score
Time frame: From Baseline to Day 35
The CSFQ is a subject-rated scale designed to measure changes in sexual function and is a structured, self-report, 14-item questionnaire, that measures sexual functioning as a total score (all 14 items), and on the subscales of pleasure, desire/frequency, desire/interest, arousal, and orgasm, rated on a 5 point scale, with each item rated from 1 to 5, and a total score range of 14 to 70. Lower scores are associated with worsened sexual functioning.
1 secondary outcome
Proportion of subjects meeting criteria for sexual dysfunction.
Time frame: 5 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
Maju Mathews, MD study director
Forest Laboratories
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vilazodone 20 mg, Vilazodone 40 mg and Paroxetine 20 mg in people with Healthy, run by Forest Laboratories at 4 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 4 inclusion and 4 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Changes in Sexual Functioning Questionnaire (CSFQ) total score (time frame: From Baseline to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2015.