POC Study in Partially Responsive Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: PF-06372865.
Intervention description: Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Intervention MeSH terms: PF-06372865
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PF 06372865; generalized anxiety disorder; outpatient; safety; efficacy; suboptimal response

Summary:

      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.
    

Eligibility criteria:

        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.