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Status:

TERMINATED

POC Study in Partially Responsive Generalized Anxiety Disorder

Lead Sponsor:

Pfizer

Conditions:

Generalized Anxiety Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2015

    Estimated Enrollment :

    90 Patients enrolled

    Trial Details

    Trial ID

    NCT02310568

    Start Date

    November 1 2014

    End Date

    October 1 2015

    Last Update

    January 9 2017

    Active Locations (47)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (47 locations)

    1

    Comprehensive Clinical Development, Inc.

    Cerritos, California, United States, 90703

    2

    Pharmacology Research Institute

    Encino, California, United States, 91316

    3

    Sun Valley Research Center

    Imperial, California, United States, 92251

    4

    Excell Research, Inc.

    Oceanside, California, United States, 92056