POC Study in Partially Responsive Generalized Anxiety Disorder
NCT ID: NCT02310568
Last Updated: 2017-01-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
90 participants
INTERVENTIONAL
2014-11-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PF 06372865 2.5 mg BID then placebo.
PF 06372865 2.5 mg tablet 2 times daily for 4 weeks (Stage 1), followed by placebo 2 times daily for 4 weeks (Stage 2).
PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
PF 06372865 7.5 mg BID then placebo.
PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 1), followed by placebo (2 times daily) for 4 weeks (Stage 2).
PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Placebo then PF 06372865 2.5 mg BID.
Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks
PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Placebo then PF 06372865 7.5 mg BID.
Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 2).
PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Placebo followed by placebo.
Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2).
PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Interventions
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PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Eligibility Criteria
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Inclusion Criteria
2. Diagnostic and Statistical Manual of Mental Disorders Fourth edition Text Revised (DSM IV TR) diagnosis of GAD (DSM IV TR, 300.02), confirmed as primary diagnosis by the Mini international neuropsychiatric interview (MINI) structured interview.
3. All subjects must have a total HAM A (via SIGH A) score 22 at screening. In addition, scores at the baseline visit must also be within 20% of scores at screening.
4. Subjects must also have a Covi Anxiety Scale score of 9 and a Raskin Depression Scale score 7 at the Screening (Visit 1) visit to ensure predominance of anxiety symptoms over depression symptoms.
5. Taking an FDA approved GAD treatment (escitalopram 10 to 20 mg total daily dose, paroxetine 20 to 50 mg total daily dose, duloxetine 60 to 120 mg total daily dose, or venlafaxine 75 to 225 mg total daily dose) at a stable FDA approved dosage for at least the two consecutive months in the current episode immediately prior to the screening visit. Sertraline or citalopram are also permitted as background treatment for GAD at doses of 50 to 200 mg total daily dose and 20 to 40 mg total daily dose, respectively.
Exclusion Criteria
2. Recent (defined as meeting disorder diagnostic criteria during the last 6 months) of a DSM IV TR Axis I diagnosis other than generalized anxiety disorder, with the following exceptions: a. Subjects with recent (in the last 2 months) major depressive disorder may be enrolled if the anxiety symptoms are predominant over the depressive symptoms, as judged by the Covi/Raskin criteria listed above and confirmed GAD as the primary diagnosis by the MINI structured interview. b. Comorbid social phobia and/or specific phobias are permitted as long as the anxiety symptoms due to these disorders are clinically less significant than the anxiety symptoms due to GAD and GAD is confirmed as the primary diagnosis by the MINI structured interview.
3. Recent (defined as meeting disorder diagnostic criteria during the last 6 months) of a DSM IV TR Axis I of panic disorder with or without agoraphobia, Post Traumatic Stress Disorder (PTSD), dissociative disorder, obsessive compulsive disorder, attention deficit disorder. If a subject has a past misdiagnosis of any of these disorders, or if the subject has another psychiatric disorder that in the opinion of the investigator affects the suitability of a subject for this study based on safety or other considerations, the investigator will need to contact the sponsor prior to screening.
4. Past and/or current DSM IV TR diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
5. Presence of comorbid personality disorders (Axis II) based on DSM IV TR.
6. Subjects who meet DSM IV TR defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM IV TR defined substance abuse within 3 months prior to screening.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Comprehensive Clinical Development, Inc.
Cerritos, California, United States
Pharmacology Research Institute
Encino, California, United States
Sun Valley Research Center
Imperial, California, United States
Excell Research, Inc.
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Institute of Living
Hartford, Connecticut, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Gulfcoast Clinical Center
Fort Meyers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Berma Research Group
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Sarkis Clinical Trials
Lake City, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Roswell, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Phoenix Medica Research, Inc
Prairie Village, Kansas, United States
Pharmasite Research Inc
Baltimore, Maryland, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
BCCR Trials
Natick, Massachusetts, United States
Premier Psychiatric Research Institute. LLC.
Lincoln, Nebraska, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
SPRI Clinical Trials LLC
Brooklyn, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Comprehensive Clinical Development, Inc.
Jamaica, New York, United States
Bioscience Research LLC
Mount Kisco, New York, United States
Fieve Clinical Research, Inc
New York, New York, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Suburban Research Associates
Media, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Futuresearch Trials of Dallas
Dallas, Texas, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Countries
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References
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Targum SD, Murphy C, Khan J, Zumpano L, Whitlock M, Simen AA, Binneman B. Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder. Innov Clin Neurosci. 2018 Apr 1;15(3-4):37-42.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7431007
Identifier Type: -
Identifier Source: org_study_id
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