POC Study in Partially Responsive Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02310568
• Other study ID #: B7431007
• Status: Terminated
• Phase: Phase 2
• First received: October 24, 2014
• Last updated: December 11, 2015
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• PF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.

Locations

Country	Name	City	State
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Pharmasite Research Inc	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	SPRI Clinical Trials LLC	Brooklyn	New York
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Comprehensive Clinical Development, Inc.	Cerritos	California
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	InSite Clinical Research, LLC	DeSoto	Texas
United States	Pharmacology Research Institute	Encino	California
United States	Gulfcoast Clinical Center	Fort Meyers	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Institute of Living	Hartford	Connecticut
United States	Berma Research Group	Hialeah	Florida
United States	Sun Valley Research Center	Imperial	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Comprehensive Clinical Development, Inc.	Jamaica	New York
United States	Sarkis Clinical Trials	Lake City	Florida
United States	Premier Psychiatric Research Institute. LLC.	Lincoln	Nebraska
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	ActivMed Practices & Research, Inc	Methuen	Massachusetts
United States	Bioscience Research LLC	Mount Kisco	New York
United States	BCCR Trials	Natick	Massachusetts
United States	Fieve Clinical Research, Inc	New York	New York
United States	Excell Research, Inc.	Oceanside	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Phoenix Medica Research, Inc	Prairie Village	Kansas
United States	Northwest Behavioral Research Center	Roswell	Georgia
United States	Artemis Institute for Clinical Research	San Diego	California
United States	California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)	San Diego	California
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Stedman Clinical Trials	Tampa	Florida
United States	Family Psychiatry of The Woodlands	The Woodlands	Texas
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Pacific Clinical Research Medical Group	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hamilton Anxiety Rating Scale (HAM A) total score in stage 1	Change from baseline during Stage 1 of the study using the Hamilton Anxiety Rating Scale (HAM A) total score.	Weekly ratings over an 8 week timeframe	No
Primary	Change from baseline in Hamilton Anxiety Rating Scale (HAM A) total score in stage 1 and 2 combined	Anxiolytic efficacy of PF 06372865, combining study Stages 1 and 2 (placebo non responders only for Stage 2), using the Hamilton Anxiety Rating Scale (HAM A).	Weekly ratings over an 8 week timeframe	No
Secondary	Change from baseline in Hamilton Anxiety Rating Scale (HAM A) total score in stage 2	Anxiolytic efficacy of PF 06372865, during Stage 2 of the study, in the subsets of subjects who respond and the subset of subjects who do not respond to placebo in Stage 1 of the study	Weekly ratings over an 8 week timeframe	No
Secondary	Change from baseline in Sheehan Disability Scale scores	Evaluate the effects on functioning of PF 06372865 using the Sheehan Disability Scale (SDS).	Weekly ratings over an 8 week timeframe	No
Secondary	Change from baseline in Hamilton Anxiety Rating Scale across time	Characterize the time course of anxiolytic efficacy associated with PF 06372865 administration	Weekly ratings over an 8 week timeframe	No
Secondary	Remission rates, defined based on the Hamilton Anxiety Rating Scale	Evaluate the effects on HAM A total score response and remission rates with PF 06372865 administration	Weekly ratings over an 8 week timeframe	No
Secondary	Change from baseline in the Clinical Global Impression - Improvement Scale score	Evaluate the effects of PF 06372865 on a global clinical endpoint using the Clinical Global Impression Improvement (CGI I) scale	Weekly ratings over an 8 week timeframe	No
Secondary	Change from baseline in the Clinical Global Impression- Severity Scale	Evaluate the effects of PF 06372865 on a global clinical endpoint using the Clinical Global Impression Severity (CGI S) scale	Weekly ratings over an 8 week timeframe	No
Secondary	Plasma drug concentration (ng/mL)	PF 06372865 plasma concentrations	Week 2, 3, 4, 6, 7 and 8	No
Secondary	Change from baseline in the Hamilton Anxiety Rating Scale, Psychic and Somatic subscales	Assess the efficacy of PF 06372865 compared to placebo on the psychic and somatic subscales of the HAM A	Weekly ratings over an 8 week timeframe	No