POC Study in Partially Responsive Generalized Anxiety Disorder
Generalized Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring PF 06372865, generalized anxiety disorder, outpatient, safety, efficacy, suboptimal response
Eligibility Criteria
Inclusion criteria:
- Outpatient males and females 18 65 years of age (inclusive).
- 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.
- 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.
- 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.
- 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:
- Subjects with a history of daily benzodiazepine use within one month of the screening visit.
- 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.
- 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.
- 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).
- Presence of comorbid personality disorders (Axis II) based on DSM IV TR.
- 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.
Sites / Locations
- Comprehensive Clinical Development, Inc.
- Pharmacology Research Institute
- Sun Valley Research Center
- Excell Research, Inc.
- NRC Research Institute
- California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
- Artemis Institute for Clinical Research
- Pacific Clinical Research Medical Group
- Hartford Hospital
- Institute of Living
- Avail Clinical Research, LLC
- Gulfcoast Clinical Center
- Sarkis Clinical Trials
- Berma Research Group
- Clinical Neuroscience Solutions, Inc.
- Sarkis Clinical Trials
- Medical Research Group of Central Florida
- Clinical Neuroscience Solutions, Inc.
- Stedman Clinical Trials
- Institute for Advanced Medical Research
- Atlanta Center for Medical Research
- Northwest Behavioral Research Center
- Great Lakes Clinical Trials
- Phoenix Medica Research, Inc
- Pharmasite Research Inc
- Beacon Clinical Research, LLC
- ActivMed Practices & Research, Inc
- BCCR Trials
- Premier Psychiatric Research Institute. LLC.
- Center for Emotional Fitness
- Bio Behavioral Health
- SPRI Clinical Trials LLC
- Neurobehavioral Research, Inc.
- Comprehensive Clinical Development, Inc.
- Bioscience Research LLC
- Fieve Clinical Research, Inc
- Patient Priority Clinical Sites, LLC
- CTI Clinical Research Center
- Cutting Edge Research Group
- Summit Research Network (Oregon) Inc.
- Suburban Research Associates
- Clinical Neuroscience Solutions, Inc.
- Futuresearch Trials of Dallas
- InSite Clinical Research, LLC
- Family Psychiatry of The Woodlands
- Northwest Clinical Research Center
- Summit Research Network (Seattle) LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
PF 06372865 2.5 mg BID then placebo.
PF 06372865 7.5 mg BID then placebo.
Placebo then PF 06372865 2.5 mg BID.
Placebo then PF 06372865 7.5 mg BID.
Placebo followed by 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 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).
Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks
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).
Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2).