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

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: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Drug: PRX-00023

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: Interventional
• Enrollment: 310
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Collaborators and Investigators

• Sponsor: Epix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: November 2, 2005
• First Submitted That Met QC Criteria: November 2, 2005
• First Posted (Estimate): November 3, 2005

Study Record Updates

• Last Update Posted (Estimate): April 3, 2008
• Last Update Submitted That Met QC Criteria: April 2, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Naluzotan
• Other Study ID Numbers: PRX-CP-007