Anxiety DisordersPhase 3NCT00248183
A Study To Evaluate PRX-00023 In Patients With Generalized Anxiety Disorder (GAD)
A Phase 3 study testing PRX-00023 in people with Anxiety Disorders, run by Epix Pharmaceuticals, Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- PRX-00023
- How many people
- 310 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2005to Jun 2006
- Phase
- Phase 3
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 37Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Anaheim Research Center
Anaheim, California, 92801
Atlanta Institute of Research and Medicine
Atlanta, Georgia, 30328
Future Search Trials
Austin, Texas, 78756
Sidney Lerfald, MD
Charleston, West Virginia, 25301
Connecticut Clinical Research
Cromwell, Connecticut, 06416
UT Southwestern Medical Center
Dallas, Texas, 75235
Comprehensive Neurosciences
Falls Church, Virginia, 22041
Gulf Coast Clinical Research Center
Fort Myers, Florida, 33912
Comprehensive Neurosciences
Kenilworth, New Jersey, 07033
Northwest Behavioral Research
Marietta, Georgia, 30060
Vista Medical Research
Mesa, Arizona, 85206
Pivotal Research Center
Mesa, Arizona, 85210
Louisiana Research Associates
New Orleans, Louisiana, 70114
Mount Sinai School of Medicine
New York, New York, 10029
Unversity of Pennsylvania
Philadelphia, Pennsylvania, 19140
Oregon Center for Clinical Investigations
Portland, Oregon, 97210
Pivotal Research Center
Royal Oak, Michigan, 48073
Oregon Center for Clinical Investigations
Salem, Oregon, 97301
Pacific Clinical Research Group
Upland, California, 91739
The George Washington University
Washington D.C., District of Columbia, 20037
About this study
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)
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- PRX-00023
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-00023Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startAug 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 310 participants
Sponsor and investigators
- Lead sponsor
- Epix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248183
- Sponsor's protocol ID
- PRX-CP-007
- Status last verified
- Apr 2008
- First submitted
- 2 Nov 2005
- Last updated
- 3 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00248183
- Acronym / sponsor ID
- PRX-CP-007
- Conditions
- Anxiety Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants
- Lead sponsor
- Epix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 3 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX-00023 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
Related trials for Anxiety Disorders
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRX-00023 in people with Anxiety Disorders, run by Epix Pharmaceuticals, Inc. at 20 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 10 inclusion and 37 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 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
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 3 Apr 2008.