POC Study in Partially Responsive Generalized Anxiety Disorder

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of PF-06372865 compared to placebo.

Key facts

Study ID

NCT02310568

Run by

Pfizer

People needed

90

Starts

2014-11-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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