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Fut, nem toboroz3. fázis

Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder

A legfontosabb adatok

Ki végzi
Vanda Pharmaceuticals
Hol
Albuquerque, Atlanta, Charlotte, Denver, Encino, Houston, Jacksonville, Las Vegas, Miami, Mission Viejo, New Orleans, New York, Orem, Orlando, Phoenix, Pikesville, Princeton, Rockville, Saint Charles, San Diego, San Jose, Scottsdale, St Louis, Suwanee, Tampa, Towson, Walnut Creek, Wichita Falls és Wilmington (Egyesült Államok)Mind a 29 helyszín megnézése
Azonosító
Állapot
Fut, nem toboroz
Fázis
3. fázis
Résztvevők
500 fő, tervezett
Kezdés
2025. szept. 22.
Várható befejezés
2027. ápr.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • VQW-765
  • Placebo
A regiszteradat frissítve
2026. augusztus 17.

Ki vehet részt

Életkor
18 év – 65 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

  • Ability and willingness to provide written informed consent
  • Male and female subjects aged 18-65 years, inclusive
  • Current diagnosis of social anxiety disorder
  • Liebowitz Social Anxiety Scale total score ≥60
  • Public Speaking Anxiety Scale total score ≥60
  • Hamilton Depression Rating Scale score ≤18

Ki nem vehet részt

  • Psychotropic medication in the past 2 months
  • History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder
  • Posttraumatic stress disorder or an eating disorder in the past 6 months
  • Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening
  • Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator
  • Psychotherapy in the past 6 months
  • Current or planned pregnancy or nursing during the trial period
  • Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives

Helyszínek itt: Egyesült Államok

  • Albuquerque, New MexicoHospital not named in the registry
  • Atlanta, GeorgiaHospital not named in the registry
  • Charlotte, North CarolinaHospital not named in the registry
  • Denver, ColoradoHospital not named in the registry
  • Encino, CaliforniaHospital not named in the registry
  • Houston, TexasHospital not named in the registry
  • Jacksonville, FloridaHospital not named in the registry
  • Las Vegas, NevadaHospital not named in the registry
  • Miami, FloridaHospital not named in the registry
  • Mission Viejo, CaliforniaHospital not named in the registry
  • New Orleans, LouisianaHospital not named in the registry
  • New YorkHospital not named in the registry
  • Orem, UtahHospital not named in the registry
  • Orlando, FloridaHospital not named in the registry
  • Phoenix, ArizonaHospital not named in the registry
  • Pikesville, MarylandHospital not named in the registry
  • Princeton, New JerseyHospital not named in the registry
  • Rockville, MarylandHospital not named in the registry
  • Saint Charles, MissouriHospital not named in the registry
  • San Diego, CaliforniaHospital not named in the registry
  • San Jose, CaliforniaHospital not named in the registry
  • Scottsdale, ArizonaHospital not named in the registry
  • St Louis, MissouriHospital not named in the registry
  • Suwanee, GeorgiaHospital not named in the registry
  • Tampa, FloridaHospital not named in the registry
  • Towson, MarylandHospital not named in the registry
  • Walnut Creek, CaliforniaHospital not named in the registry
  • Wichita Falls, TexasHospital not named in the registry
  • Wilmington, North CarolinaHospital not named in the registry

A vizsgálatról

Mit akar kideríteni a vizsgálat

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 adults with social anxiety disorder.

A vizsgálat 2 csoportja

  • VQW-765A vizsgált kezelés
  • PlaceboPlacebo, összehasonlításként

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder
A regiszteradat frissítve
2026. augusztus 17.