A Study To Evaluate PRX-00023 In Patients With Generalized Anxiety Disorder (GAD)

April 2, 2008 updated by: Epix Pharmaceuticals, Inc.

A Randomized, Double Blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy, Safety, And Tolerability Of PRX-00023 In Patients With Generalized Anxiety Disorder (GAD)

This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in adults with GAD.

Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who fulfill the inclusion/exclusion criteria, will be enrolled in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in adults with GAD.

Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who fulfill the inclusion/exclusion criteria, will be enrolled in this study.

This is a randomized, double-blind, placebo controlled, multi-center outpatient study, in adults with GAD.

Patients 18-65 years of age, with the diagnosis of GAD according to DSM-IV criteria, who fulfill the inclusion/exclusion criteria, will be enrolled in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotal Research Center
      • Mesa, Arizona, United States, 85206
        • Vista Medical Research
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Research Center
      • Upland, California, United States, 91739
        • Pacific Clinical Research Group
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Connecticut Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Gulf Coast Clinical Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Research and Medicine
      • Marietta, Georgia, United States, 30060
        • Northwest Behavioral Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Pivotal Research Center
    • New Jersey
      • Kenilworth, New Jersey, United States, 07033
        • Comprehensive Neurosciences
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Center for Clinical Investigations
      • Salem, Oregon, United States, 97301
        • Oregon Center for Clinical Investigations
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Unversity of Pennsylvania
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22041
        • Comprehensive Neurosciences
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Sidney Lerfald, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be male or female, 18-65 years of age
  • Meet DSM-IV diagnostic criteria for Generalized Anxiety Disorder (GAD)
  • Have a total score of ≥ 20 on the HAM-A and a score of ≥ 2 on Items 1 and 2 (anxious mood and tension) of the HAM-A
  • Have no more than a 20% decrease in total HAM-A score during the period from the screening visit to the randomization visit
  • Have a negative serum (β-HCG) pregnancy test at screening and a negative urine pregnancy test at baseline (for all women)
  • Female subjects must meet one of the following criteria: (a) Be surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least six months prior to first dose of PRX-00023; appropriate documentation will be required) OR (b) Agree that, if sexually active, they and all male partners will use two (2) acceptable barrier forms of contraception (e.g., condoms and diaphragm) from screening until one month after the final dose of study drug
  • Male subjects must agree that they and any female partners will use two(2) acceptable forms of contraception (e.g., condoms and hormonal contraceptives) from screening until one month following the final dose of study drug
  • Be in generally good physical health as determined by the Investigator on the basis of medical history, physical examination, and screening laboratory results
  • Have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described
  • Be able to understand procedures and provide written informed consent prior to admission

Exclusion Criteria:

  • A history of an inability to tolerate, or a failure to respond to, two or more anxiolytic or anti-depressant drugs given in adequate doses and duration for the treatment of symptoms present in the current illness
  • Prior intolerance to buspirone, gepirone, tandospirone or other 5HT1A agonist
  • A current or past history of mania, bipolar disorder, schizophrenia, or other psychotic disorder
  • A current history (or within the six months prior to screening) of panic disorder, post traumatic stress disorder, major depression, obsessive-compulsive disorder, social phobia, acute stress disorder, adjustment disorder with anxious mood, performance anxiety, somatization disorder, or other principle psychiatric diagnosis (DSM-IV) which could interfere with the efficacy assessments
  • A history of a major life event (e.g. divorce, death of family member) which in the opinion of the Investigator is likely to alter the efficacy ratings during the course of the study
  • Clinically significant abnormalities on laboratory tests or ECG (includes QTc value >450 msec in males or > 470 msec in females)
  • The presence of a serious or clinically unstable neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematologic or other medical illness or psychiatric condition that would, in the opinion of the Investigator, compromise participation in the study, confound study results, or likely lead to the need for early termination of study participation or hospitalization during the course of the study
  • A history of allergic reactions to two or more medications of different chemical classes
  • Use of any non-prescription drug with psychotropic effects within seven (7) days prior to initiation of the placebo lead in
  • Chronic use of analgesics with opiates (e.g., codeine, hydrocodone, oxycodone) for >6 months or use of opiates within two weeks prior to screening
  • Introduction or change in cognitive behavioral therapy, interpersonal therapy, or other psychotherapy within three months of screening
  • Use of St. John's Wort, kava kava, ephedra, or other psychoactive herbal medications within the last two weeks before screening
  • Known or suspected substance abuse or dependence, including alcohol, within one year of screening
  • A positive urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, and propoxyphene) at screening. The urine drug screen may be repeated once if after discussion with the patient there is a plausible reason for the positive test other than substance abuse
  • A history of suicide attempts in the last two years, or current suicide risk in the judgment of the Investigator
  • Women who are breast feeding, have been lactating within three months prior to screening, pregnant, expect to become pregnant during the course of the study, or are sexually active and are not using a medically acceptable double barrier method of birth control. Women relying solely on oral contraceptives for - The use of any investigational drug within 30 days prior to enrollment
  • The concomitant use of any other antidepressants, anxiolytics, or any other psychoactive drugs
  • Treatment with any potent inhibitor of CYP3A4, including ketoconazole, itraconazole, HIV protease inhibitors, clarithromycin, erythromycin, cyclosporine
  • Treatment with CYP3A4 inducers such as carbamazepine, barbiturates, phenytoin, rifampin, or oral glucocorticoids
  • Treatment with any of the psychoactive drugs listed in the table below within the interval specified below before enrollment

  • Psychoactive drug - Interval (weeks)

    • MAO Inhibitors - 4
    • Fluoxetine - 4
    • Fluvoxamine - 2
    • Citalopram - 2
    • Paroxetine - 2
    • Sertraline - 2
    • Buspirone - 4
    • Buproprion - 2
    • Mirtazepine - 2
    • Nefazodone - 2
    • Venlafaxine - 2
    • Duloxetine - 2
    • Trazodone - 2
    • Benzodiazepines Occasional or PRN use: - 1
    • Chronic or daily use: - 4
    • Tricyclic and Heterocyclic Antidepressants - 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Epix Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRX-CP-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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