POC Study in Partially Responsive Generalized Anxiety Disorder



Status:Terminated
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:November 2014
End Date:October 2015

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An 8-week, Randomized, Phase 2, Double-blind, Sequential Parallel-group Comparison Study Of Two Dose Levels Of Pf 06372865 Compared To Placebo As An Adjunctive Treatment In Outpatients With Inadequate Response To Standard Of Care For Generalized Anxiety Disorder

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.


Inclusion criteria:

1. Outpatient males and females 18 65 years of age (inclusive).

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:

1. Subjects with a history of daily benzodiazepine use within one month of the screening
visit.

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.
We found this trial at
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Cerritos, California 90703
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
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2417 Marshall Ave.
Imperial, California 92251
760-355-0176
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901 Boren Avenue
Seattle, Washington 98104
206-624-4587
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3212 Cove Bend Drive
Tampa, Florida 33613
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Alpharetta, Georgia 30005
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Baltimore, Maryland 21208
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Bellevue, Washington 98007
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Brockton, Massachusetts 02301
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Brooklyn, New York 11235
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Cedarhurst, New York 11516
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Chicago, Illinois 60640
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Cincinnati, Ohio 45227
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Cincinnati, Ohio 45242
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Dallas, Texas 75231
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DeSoto, Texas 75115
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Encino, California 91316
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Fort Meyers, Florida 33912
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Gainesville, Florida 32607
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Hartford, Connecticut 06106
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Hialeah, Florida 33016
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Jacksonville, Florida 32216
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Jamaica, New York 11432
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Lake City, Florida 32025
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Media, Pennsylvania 19063
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Media, Pennsylvania 19063
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Memphis, Tennessee 38119
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Methuen, Massachusetts 01844
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Mount Kisco, New York 10549
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Natick, Massachusetts 07160
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The Woodlands, Texas 77381
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