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About
The purpose of this study is to look at the safety and effectiveness of an investigational drug (AV608) when used in subjects who have Social Anxiety Disorder. AV608 is an NK-1 receptor antagonist that exhibits central nervous system activity after oral administration. The study will compare AV608 to placebo (a medically inactive substance) to see if AV608 helps the symptoms of Social Anxiety Disorder. Eligible subjects will be assigned by chance to take either AV608 or placebo for 12 weeks. During the study, subjects will be asked about their overall health and mood and their Social Anxiety Disorder.
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Inclusion criteria
Exclusion criteria
The subject has a decrease >15 points on the LSAS total score between Screening (Visit 1) and Baseline (Visit 2).
The subject has a clinically significant abnormality or clinically significant unstable medical condition as indicated by medical history, physical examination, ECG results, clinical laboratory testing, or the investigator's judgment at Screening (Visit 1) or Baseline (Visit 2).
The subject has a QTc interval of 450 msec or greater at Screening (Visit 1) if male or a QTc interval of 470 msec or greater at Screening (Visit 1) if female.
The subject has current hypothyroidism or hyperthyroidism or laboratory findings consistent with thyroid dysfunction. Subjects who are being treated for thyroid disorder are eligible if they have been on stable doses of thyroid hormone for at least 6 months and are currently euthyroid.
The subject has any history of schizophrenia or other psychotic disorder, bipolar disorder, post-traumatic stress disorder, borderline personality disorder, or antisocial personality disorder.
The subject has a history within the previous 5 years of obsessive-compulsive disorder or an eating disorder.
The subject exhibits evidence of a clinically predominant DSM-IV-TR Axis I or II disorder other than Social Phobia or Avoidant Personality Disorder within the 6 months prior to Screening (Visit 1).
The subject, in the opinion of the investigator, presents a significant risk of doing harm to himself, herself, or others.
The subject has met DSM-IV-TR criteria for alcohol or substance dependence (other than nicotine or caffeine dependence) within 6 months of Screening (Visit 1).
The subject has met DSM-IV-TR criteria substance abuse (other than alcohol, nicotine or caffeine abuse) within 3 months of Screening (Visit 1).
The subject tests positive on the urine drug screen conducted at Screening (Visit 1) for illicit drugs, including opiates, barbiturates, amphetamines, cocaine, and phencyclidine.
The subject is a pregnant or lactating female.
The subject has previously participated in a clinical trial for AV608 (previously identified as NKP608 and CGP608).
The subject has used any prohibited medications, or has any anticipated need or intended use of these medications during the study, including:
The subject has used any investigational drugs, products, or devices in the 3 months prior to Screening (Visit 1).
The subject is a member of the investigative site staff or an immediate family member.
The subject has any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the trial protocol.
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Data sourced from clinicaltrials.gov
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