Performance AnxietyPhase 2NCT04800237
Evaluating the Effects of VQW-765 vs. Placebo in Performance Anxiety
A Phase 2 study testing VQW-765 in people with Performance Anxiety, run by Vanda Pharmaceuticals at 15 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in male and female participants with performance anxiety. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Anxiety
- What is being tested?
- VQW-765
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 15 sitesUnited States
- Study dates
- 23 Feb 2021to 2 Aug 2022
- Phase
- Phase 2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent.
- Sufficiently fluent in English to participate in the trial.
- Male and female patients aged 18-70 years (inclusive).
Who cannot join
- Lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder.
- Current or planned pregnancy or nursing during the trial period.
- A positive test for substances of abuse.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Vanda Investigational Site
Berlin, New Jersey, 08009
Vanda Investigational Site
Beverly Hills, California, 90212
Vanda Investigational Site
Boston, Massachusetts, 02114
Vanda Investigational Site
Cincinnati, Ohio, 45212
Vanda Investigational Site
Garden Grove, California, 92845
Vanda Investigational Site
Houston, Texas, 77074
Vanda Investigational Site
Las Vegas, Nevada, 89119
Vanda Investigational Site
New York, New York, 10016
Vanda Investigational Site
North Dartmouth, Massachusetts, 02747
Vanda Investigational Site
Orlando, Florida, 32816
Vanda Investigational Site
Raleigh, North Carolina, 27612
Vanda Investigational Site
San Jose, California, 95124
Vanda Investigational Site
Staten Island, New York, 10312
Vanda Investigational Site
Tempe, Arizona, 85281
Vanda Investigational Site
Torrance, California, 90502
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in male and female participants with performance anxiety.
- Conditions
- Performance Anxiety
- Being tested
- VQW-765, Placebo
- Keywords
- social phobia, social anxiety disorder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VQW-765Drug
oral capsule
PlaceboDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| VQW-765 | Experimental | Not described Receives: Drug: VQW-765 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Units of Distress Scale (SUDS)
Measured: 1 Day
Secondary outcomes (3)
Clinician Global Impression of Change (CGI-C) scale at visit 2
Measured: 1 Day
Patient Global Impression of Change (PGI-C) scale at visit 2
Measured: 1 Day
Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start23 Feb 2021
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance AnxietyStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800237
- Sponsor's protocol ID
- VP-VQW-765-2201
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety
- ClinicalTrials.gov ID
- NCT04800237
- Acronym / sponsor ID
- VP-VQW-765-2201
- Conditions
- Performance Anxiety
- Keywords
- social phobia, social anxiety disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- 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.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in male and female participants with performance anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VQW-765 | Experimental | Drug: VQW-765 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability and willingness to provide written informed consent.
- Sufficiently fluent in English to participate in the trial.
- Male and female patients aged 18-70 years (inclusive).
Key exclusion criteria (3 listed)
- Lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder.
- Current or planned pregnancy or nursing during the trial period.
- A positive test for substances of abuse.
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 |
|---|---|---|
| VQW-765oral capsule | Drug | VQW-765 |
| Placebooral capsule | Drug | Placebo |
Primary outcome
Subjective Units of Distress Scale (SUDS)
Time frame: 1 Day
3 secondary outcomes
Clinician Global Impression of Change (CGI-C) scale at visit 2
Time frame: 1 Day
Patient Global Impression of Change (PGI-C) scale at visit 2
Time frame: 1 Day
Assessment of safety and tolerability of a single dose of VQW-765, as measured by spontaneous reporting of adverse events (AEs)
Time frame: 1 Day
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VQW-765 in people with Performance Anxiety, run by Vanda Pharmaceuticals 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 3 inclusion and 3 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 20 Mar 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Subjective Units of Distress Scale (SUDS) (time frame: 1 Day). 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 20 Mar 2024.