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Clinical trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of VQW-765 in Patients With Performance Anxiety

ID
Name
VP-VQW-765-2201
Description
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.
Trial arms
Trial start
2021-02-23
Estimated PCD
2022-08-02
Trial end
2022-08-02
Status
Completed
Phase
Early phase I
Treatment
VQW-765
oral capsule
Arms:
VQW-765
Placebo
oral capsule
Arms:
Placebo
Size
230
Primary endpoint
Subjective Units of Distress Scale (SUDS)
1 Day
Eligibility criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 230, 'type': 'ACTUAL'}}
Updated at
2024-03-20

1 organization

2 products

1 indication

Organization
Vanda Pharmaceuticals
Product
Placebo
Indication
Social Anxiety Disorder
Product
VQW-765