Generalized Anxiety DisorderPhase 2NCT02310568
POC Study in Partially Responsive Generalized Anxiety Disorder
A Phase 2 study testing PF-06372865. in people with Generalized Anxiety Disorder, run by Pfizer at 47 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- PF-06372865.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 47 sitesUnited States
- Study dates
- Nov 2014to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Pharmasite Research Inc
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98007
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301
SPRI Clinical Trials LLC
Brooklyn, New York, 11235
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Comprehensive Clinical Development, Inc.
Cerritos, California, 90703
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45215
CTI Clinical Research Center
Cincinnati, Ohio, 45227
Futuresearch Trials of Dallas
Dallas, Texas, 75231
Avail Clinical Research, LLC
DeLand, Florida, 32720
InSite Clinical Research, LLC
DeSoto, Texas, 75115
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Center
Fort Meyers, Florida, 33912
Sarkis Clinical Trials
Gainesville, Florida, 32607
Hartford Hospital
Hartford, Connecticut, 06102
Institute of Living
Hartford, Connecticut, 06106
Berma Research Group
Hialeah, Florida, 33016
Sun Valley Research Center
Imperial, California, 92251
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Comprehensive Clinical Development, Inc.
Jamaica, New York, 11432
Sarkis Clinical Trials
Lake City, Florida, 32025
Premier Psychiatric Research Institute. LLC.
Lincoln, Nebraska, 68526
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844
Bioscience Research LLC
Mount Kisco, New York, 10549
BCCR Trials
Natick, Massachusetts, 07160
Fieve Clinical Research, Inc
New York, New York, 10168
Excell Research, Inc.
Oceanside, California, 92056
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
NRC Research Institute
Orange, California, 92868
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Phoenix Medica Research, Inc
Prairie Village, Kansas, 66206
Northwest Behavioral Research Center
Roswell, Georgia, 30076
California Neuorpsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
San Diego, California, 92102
Artemis Institute for Clinical Research
San Diego, California, 92103
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
Stedman Clinical Trials
Tampa, Florida, 33613
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
Bio Behavioral Health
Toms River, New Jersey, 08755
Pacific Clinical Research Medical Group
Upland, California, 91786
About this study
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
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
- Being tested
- PF-06372865.
- Keywords
- PF 06372865, generalized anxiety disorder, outpatient, safety, efficacy, suboptimal response
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06372865.Drug
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 Receives: 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). Receives: 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). Receives: Drug: PF-06372865. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Week 5, 6, 7, 8
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
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.
Measured: 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
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.
Measured: 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
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.
Measured: Week 1, 2, 3
Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2
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.
Measured: Stage 1: Week 4, Stage 2: Week 8
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
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.
Measured: 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)
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
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.
Measured: 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)
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
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.
Measured: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
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.
Measured: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
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.
Measured: 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)
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
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.
Measured: 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)
Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores
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.
Measured: Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Study recruitment was terminated on 24 June 2015, due to a Pfizer business decision. This study was not terminated for reasons of safety or efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310568
- Sponsor's protocol ID
- B7431007
- Status last verified
- Sep 2016
- First submitted
- 24 Oct 2014
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29721364
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02310568
- Acronym / sponsor ID
- B7431007
- Conditions
- Generalized Anxiety Disorder
- Keywords
- PF 06372865, generalized anxiety disorder, outpatient, safety, efficacy, suboptimal response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study recruitment was terminated on 24 June 2015, due to a Pfizer business decision. This study was not terminated for reasons of safety or efficacy
- Enrolment
- 90 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Posted 15 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PF 06372865 2.5 mg BID then placebo. | Experimental | Drug: 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). |
| PF 06372865 7.5 mg BID then placebo. | Experimental | Drug: 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). |
| Placebo then PF 06372865 2.5 mg BID. | Experimental | Drug: 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 |
| Placebo then PF 06372865 7.5 mg BID. | Experimental | Drug: 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). |
| Placebo followed by placebo. | Placebo comparator | Drug: PF-06372865.Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06372865.Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration. | Drug | 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. |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2
Time frame: 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
Time frame: 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.
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2
Time frame: 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.
12 secondary outcomes
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2
Time frame: Week 5, 6, 7, 8
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
Time frame: 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
Time frame: 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
Time frame: Week 1, 2, 3
Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2
Time frame: Stage 1: Week 4, Stage 2: Week 8
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
Time frame: 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)
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
Time frame: 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)
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Time frame: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Time frame: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Time frame: 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)
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Time frame: 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)
Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores
Time frame: Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29721364Targum 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-06372865. in people with Generalized Anxiety Disorder, run by Pfizer at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 (time frame: Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.