AzTrials
AzTrials

Social PhobiaPhase 2NCT00294346

Safety and Efficacy Study of AV608 in Subjects With Social Anxiety Disorder

A Phase 2 study testing AV608 in people with Social Phobia, run by Avera Pharmaceuticals at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Social Phobia
What is being tested?
AV608
How many people
180 participants
Where
15 sitesUnited States
Study dates
Feb 2006to Dec 2006
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is male or female, 18 - 65 years of age (inclusive).
  • The subject meets current DSM-IV-TR (American Psychiatric Association, 2000) criteria for Social Phobia (300.23), generalized subtype, as confirmed by the Mini-International Neuropsychiatric Interview at Screening (Visit 1).
  • The subject has had symptoms of SAD (Social Phobia) present for at least 6 months prior to Screening (Visit 1).
  • The subject has a total score ≥ 60 on the LSAS at both Screening (Visit 1) and Baseline (Visit 2).
  • The subject has a score ≥ 4 on the Clinical Global Impression - Severity (CGI-S) scale at both Screening (Visit 1) and Baseline (Visit 2).
  • The subject has a score ≤ 15 on the 17-item Hamilton Rating Scale for Depression (HAM-D) at Screening
Show all 11Show fewer
  • The subject, if female and of child-bearing potential (not 2 years post-menopausal or surgically sterilized), must have a negative serum pregnancy test at Screening (Visit 1) and be willing to avoid pregnancy and practice adequate birth control from the time of study enrollment until 30 days after the last dose of study medication. Adequate methods of birth control are: oral contraception, intrauterine device, implantable contraceptive device, depot contraceptive, or a barrier method plus spermicide. Additional serum pregnancy tests will be administered at Visit 6, Visit 8, and Visit 9.
  • The subject, if engaged in ongoing psychotherapy for SAD or any other mental health condition, must have been attending therapy regularly for at least 3 months prior to Screening (Visit 1) and must agree to continue the same type and frequency of psychotherapy throughout the course of the study.
  • The subject agrees to refrain from blood donation during the course of the study.
  • The subject has written and oral fluency in English or Spanish.
  • The subject is willing to participate in the study, as evidenced by a signed and dated written Informed Consent Form (ICF).

Who cannot join

  • 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.
Show all 22Show fewer
  • 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:
  • Depot injection of an antipsychotic medication within 3 months prior to Baseline (Visit 2) or use of any other antipsychotic or mood stabilizing medication within 30 days prior to Baseline (Visit 2)
  • Fluoxetine within 30 days prior to Baseline (Visit 2) or any other antidepressant medication within 14 days prior to Baseline (Visit 2)
  • Any anxiolytic or sedative-hypnotic medication within 14 days prior to Baseline (Visit 2), with the exception of eszopiclone, ramelteon, zaleplon, or zolpidem if used for sleep
  • Any other psychotropic drug or substance (prescription or over-the-counter) within 7 days prior to Baseline (Visit 2), including St. John's wort, gingko biloba, chromium picolinate, kava-kava, melatonin, DHEA, diphenhydramine, ephedra, or hydroxyzine
  • Any use of pimozide, terfenadine, astemizole, or cisapride during the study
  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Claghorn-Lesem Research Clinic, LLP

    Bellaire, Texas, 77401

  • Southwestern Research, Inc.

    Beverly Hills, California, 90210

  • Birmingham Research Group, Inc.

    Birmingham, Alabama, 35216

  • Hartford Research

    Cincinnatti, Ohio, 45242

  • CNS Healthcare

    Jacksonville, Florida, 32216

  • Pivotal Research Centers

    Mesa, Arizona, 85210

  • Medical Research Network, LLC

    New York, New York, 10024

  • IPS Research Company

    Oklahoma City, Oklahoma, 73130

  • Summit Research Network

    Portland, Oregon, 97210

  • DuPont Clinical Research, Inc.

    Rockville, Maryland, 20852

  • Capital Clinical Research Associates

    Rockville, Maryland

  • Croft Group Research Center

    San Antonio, Texas, 78229

  • Affiliated Research Institute

    San Diego, California, 92108

  • Comprehensive Neuroscience, Inc.

    St. Petersburg, Florida, 33702

  • University of South Florida

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Social Anxiety Disorder

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.

Conditions
Social Phobia
Being tested
AV608
Keywords
Social Anxiety Disorder, Social Phobia
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AV608Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liebowitz Social Anxiety Scale (LSAS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

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
Double blind
Enrolment
180 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00294346
Sponsor's protocol ID
AV608-105
Status last verified
Feb 2008
First submitted
17 Feb 2006
Last updated
25 Feb 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AV608 in people with Social Phobia, run by Avera 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 11 inclusion and 22 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 25 Feb 2008. 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. 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?

Liebowitz Social Anxiety Scale (LSAS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00294346.

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 25 Feb 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in