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

NCT00248183 | Completed Phase 3

• 1 other identifier: PRX-CP-007
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Anxiety Disorders

Interventions

PRX-00023 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epix Pharmaceuticals, Inc.: lead

Study Sites (20)

Vista Medical Research

Mesa, Arizona, 85206, United States

Location

Pivotal Research Center

Mesa, Arizona, 85210, United States

Location

Anaheim Research Center

Anaheim, California, 92801, United States

Location

Pacific Clinical Research Group

Upland, California, 91739, United States

Location

Connecticut Clinical Research

Cromwell, Connecticut, 06416, United States

Location

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Gulf Coast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Atlanta Institute of Research and Medicine

Atlanta, Georgia, 30328, United States

Location

Northwest Behavioral Research

Marietta, Georgia, 30060, United States

Location

Louisiana Research Associates

New Orleans, Louisiana, 70114, United States

Location

Pivotal Research Center

Royal Oak, Michigan, 48073, United States

Location

Comprehensive Neurosciences

Kenilworth, New Jersey, 07033, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Oregon Center for Clinical Investigations

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations

Salem, Oregon, 97301, United States

Location

Unversity of Pennsylvania

Philadelphia, Pennsylvania, 19140, United States

Location

Future Search Trials

Austin, Texas, 78756, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Comprehensive Neurosciences

Falls Church, Virginia, 22041, United States

Location

Sidney Lerfald, MD

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

naluzotan

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 3, 2005
• Study Start: August 1, 2005
• Study Completion: June 1, 2006
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (20)