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

This study has been completed.
Sponsor:
Information provided by:
Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00248183
First received: November 2, 2005
Last updated: April 2, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Anxiety Disorders
Drug: PRX-00023
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Epix Pharmaceuticals, Inc.:

Estimated Enrollment: 310
Study Start Date: August 2005
Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248183

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

No publications provided

ClinicalTrials.gov Identifier: NCT00248183     History of Changes
Other Study ID Numbers: PRX-CP-007
Study First Received: November 2, 2005
Last Updated: April 2, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014