POC Study in Partially Responsive Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Drug: PF-06372865.
- Registration Number
- NCT02310568
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo then PF 06372865 7.5 mg BID. PF-06372865. 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). PF 06372865 7.5 mg BID then placebo. PF-06372865. 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). PF 06372865 2.5 mg BID then placebo. PF-06372865. 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). Placebo followed by placebo. PF-06372865. Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2). Placebo then PF 06372865 2.5 mg BID. PF-06372865. Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks
- Primary Outcome Measures
Name Time Method Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 Stage 1: Week 4, Stage 2: Week 8 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.
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) 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.
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 Week 4 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 Stage 1: Week 4, Stage 2: Week 8 A responder was defined as a participant with \>= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in 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. Percentage of responders of total HMA scale were reported.
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, "Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?" Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4 Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8 Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) The HAM-A scale was a clinician interview-administered 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. Somatic subscale of the HAM-A was the sum of 7 items. 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 28 (very severe), where lower scores indicates less anxiety.
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 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.
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 SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) The HAM-A scale was a clinician interview-administered 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. Psychic subscale of the HAM-A was the sum of 7 items. 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 28 (very severe), where lower scores indicates less anxiety.
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) SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.
Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8 Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in 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.
Trial Locations
- Locations (43)
Gulfcoast Clinical Center
🇺🇸Fort Meyers, Florida, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Pharmacology Research Institute
🇺🇸Encino, California, United States
Phoenix Medica Research, Inc
🇺🇸Prairie Village, Kansas, United States
Comprehensive Clinical Development, Inc.
🇺🇸Jamaica, New York, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Sarkis Clinical Trials
🇺🇸Lake City, Florida, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Berma Research Group
🇺🇸Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Northwest Behavioral Research Center
🇺🇸Roswell, Georgia, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
ActivMed Practices & Research, Inc
🇺🇸Methuen, Massachusetts, United States
Pharmasite Research Inc
🇺🇸Baltimore, Maryland, United States
BCCR Trials
🇺🇸Natick, Massachusetts, United States
Premier Psychiatric Research Institute. LLC.
🇺🇸Lincoln, Nebraska, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
SPRI Clinical Trials LLC
🇺🇸Brooklyn, New York, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Bioscience Research LLC
🇺🇸Mount Kisco, New York, United States
Fieve Clinical Research, Inc
🇺🇸New York, New York, United States
Family Psychiatry of The Woodlands
🇺🇸The Woodlands, Texas, United States
InSite Clinical Research, LLC
🇺🇸DeSoto, Texas, United States
Futuresearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
🇺🇸San Diego, California, United States
Patient Priority Clinical Sites, LLC
🇺🇸Cincinnati, Ohio, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Institute of Living
🇺🇸Hartford, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States