POC Study in Partially Responsive Generalized Anxiety Disorder

NCT02310568 | Terminated Phase 2 Results DMC

• 1 other identifier: B7431007
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 47

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 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.

Conditions

Generalized Anxiety Disorder

Keywords

PF 06372865; generalized anxiety disorder; outpatient; safety; efficacy; suboptimal response

Outcome Measures

Primary Outcomes (3)

• Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2

  The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.

  Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1

  The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.

  Week 4

• Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2

  The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.

  Stage 1: Week 4, Stage 2: Week 8

Secondary Outcomes (12)

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2

  Week 5, 6, 7, 8

• Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2

  Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2

  Stage 1: Week 4, Stage 2: Week 8

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1

  Week 1, 2, 3

• Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2

  Stage 1: Week 4, Stage 2: Week 8

Study Arms (5)

PF 06372865 2.5 mg BID then placebo.

EXPERIMENTAL

PF 06372865 2.5 mg tablet 2 times daily for 4 weeks (Stage 1), followed by placebo 2 times daily for 4 weeks (Stage 2).

Drug: PF-06372865.

PF 06372865 7.5 mg BID then placebo.

EXPERIMENTAL

PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 1), followed by placebo (2 times daily) for 4 weeks (Stage 2).

Drug: PF-06372865.

Placebo then PF 06372865 2.5 mg BID.

EXPERIMENTAL

Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks

Drug: PF-06372865.

Placebo then PF 06372865 7.5 mg BID.

EXPERIMENTAL

Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 2).

Drug: PF-06372865.

Placebo followed by placebo.

PLACEBO COMPARATOR

Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2).

Drug: PF-06372865.

Interventions

PF-06372865. DRUG

Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.

PF 06372865 2.5 mg BID then placebo.; PF 06372865 7.5 mg BID then placebo.; Placebo followed by placebo.; Placebo then PF 06372865 2.5 mg BID.; Placebo then PF 06372865 7.5 mg BID.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (47)

Comprehensive Clinical Development, Inc.

Cerritos, California, 90703, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)

San Diego, California, 92102, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Institute of Living

Hartford, Connecticut, 06106, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Gulfcoast Clinical Center

Fort Meyers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Berma Research Group

Hialeah, Florida, 33016, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Sarkis Clinical Trials

Lake City, Florida, 32025, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Northwest Behavioral Research Center

Roswell, Georgia, 30076, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Phoenix Medica Research, Inc

Prairie Village, Kansas, 66206, United States

Location

Pharmasite Research Inc

Baltimore, Maryland, 21208, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, 02301, United States

Location

ActivMed Practices & Research, Inc

Methuen, Massachusetts, 01844, United States

Location

BCCR Trials

Natick, Massachusetts, 07160, United States

Location

Premier Psychiatric Research Institute. LLC.

Lincoln, Nebraska, 68526, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

SPRI Clinical Trials LLC

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Comprehensive Clinical Development, Inc.

Jamaica, New York, 11432, United States

Location

Bioscience Research LLC

Mount Kisco, New York, 10549, United States

Location

Fieve Clinical Research, Inc

New York, New York, 10168, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45215, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45227, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Futuresearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Family Psychiatry of The Woodlands

The Woodlands, Texas, 77381, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Targum SD, Murphy C, Khan J, Zumpano L, Whitlock M, Simen AA, Binneman B. Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder. Innov Clin Neurosci. 2018 Apr 1;15(3-4):37-42.

  PMID: 29721364 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

PF-06372865

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Limitations and Caveats

All 34 centres who enrolled subjects were terminated due to internal sponsor portfolio prioritization. The decision to terminate the study was not due to any safety concern or change in the benefit:risk assessment of PF-06372865

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: December 8, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 9, 2017
• Results First Posted: November 15, 2016

Record last verified: 2016-09

Locations

US (47)