Generalized Anxiety DisorderPhase 3NCT00542685
A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
A Phase 3 study testing PD 0332334 in people with Generalized Anxiety Disorder, run by Pfizer at 43 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder. 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?
- PD 0332334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 551 participants
- Where
- 43 sitesUnited States
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
- Subjects must have a HAM-A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >9 and a Raskin Depression Scale score <7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Who cannot join
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder, Obsessive compulsive disorder, Panic disorder; Agoraphobia, Posttraumatic stress disorder, Anorexia, Bulimia, Caffeine-induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
- Any of the following past or current DSM IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Belmont, Massachusetts, 02478
Pfizer Investigational Site
Beverly Hills, California, 90210
Pfizer Investigational Site
Brooklyn, New York, 11201
Pfizer Investigational Site
Chapel Hill, North Carolina, 27514
Pfizer Investigational Site
Charleston, South Carolina, 29407
Pfizer Investigational Site
Cherry Hill, New Jersey, 08002
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Fall River, Massachusetts, 02721
Pfizer Investigational Site
Farmington, Connecticut, 06030-6415
Pfizer Investigational Site
Farmington Hills, Michigan, 48336
Pfizer Investigational Site
Glen Burnie, Maryland, 21061
Pfizer Investigational Site
Houston, Texas, 77057
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jacksonville, Florida, 32256-2006
Pfizer Investigational Site
Lafayette, Indiana, 47905
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Libertyville, Illinois, 60048
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
Nashua, New Hampshire, 03060
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
New York, New York, 10024
Pfizer Investigational Site
Newport Beach, California, 92660-2452
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Owensboro, Kentucky, 42301
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19149
Pfizer Investigational Site
Piscataway, New Jersey, 08854-5635
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Richmond, Virginia, 23230
Pfizer Investigational Site
Rockville, Maryland, 20852
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
Schaumburg, Illinois, 60194
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sherman Oaks, California, 91403
Pfizer Investigational Site
Staten Island, New York, 10312
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
West Palm Beach, Florida, 33407
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- PD 0332334, Placebo
- 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.
PD 0332334Drug
Also called imagabalin
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
PlaceboDrug
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
PD 0332334Drug
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
PD 0332334Drug
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
| Study group | Role | What they receive |
|---|---|---|
| PD 0332334 300 mg BID | Experimental | Not described Receives: Drug: PD 0332334 |
| Placebo BID | Placebo comparator | Not described Receives: Drug: Placebo |
| PD 0332334 225 mg BID | Experimental | Not described Receives: Drug: PD 0332334 |
| PD 0332334 175 mg BID | Experimental | Not described Receives: Drug: PD 0332334 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
Measured: 8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
Measured: 8 weeks
Secondary outcomes (18)
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
Measured: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
Measured: 8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.
Measured: 8 weeks
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).
Measured: 8 weeks
Response rate on the HAM-A at Week 1 and Week 8.
Measured: 8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
Measured: 8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.
Measured: 8 weeks
Response rate on the patient-rated PGI-C at Week 8.
Measured: 8 weeks
The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit).
Measured: 1 week
Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.
Measured: 6 weeks
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8.
Measured: 8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale subscales.
Measured: 8 weeks
Change from Baseline in CGI-S at Week 8.
Measured: 8 weeks
Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
Measured: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Measured: 8 weeks
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.
Measured: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Measured: 1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 551 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
- NCT00542685
- Sponsor's protocol ID
- A5361017
- Status last verified
- Nov 2012
- First submitted
- 10 Oct 2007
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00542685
- Acronym / sponsor ID
- A5361017
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD 0332334 300 mg BID | Experimental | Drug: PD 0332334 |
| Placebo BID | Placebo comparator | Drug: Placebo |
| PD 0332334 225 mg BID | Experimental | Drug: PD 0332334 |
| PD 0332334 175 mg BID | Experimental | Drug: PD 0332334 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
- Subjects must have a HAM-A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >9 and a Raskin Depression Scale score <7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Key exclusion criteria (5 listed)
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder, Obsessive compulsive disorder, Panic disorder; Agoraphobia, Posttraumatic stress disorder, Anorexia, Bulimia, Caffeine-induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
- Any of the following past or current DSM IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.
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 |
|---|---|---|
| PD 0332334Also: imagabalinCapsules, oral, 300 mg BID, 8 weeks with 2 week taper. | Drug | PD 0332334 300 mg BID |
| PlaceboCapsules, oral, placebo BID, 8 weeks with 2 week taper. | Drug | Placebo BID |
| PD 0332334Capsules, oral, 225 mg BID, 8 weeks with 2 week taper. | Drug | PD 0332334 225 mg BID |
| PD 0332334Capsules, oral, 175 mg BID, 8 weeks with 2 week taper. | Drug | PD 0332334 175 mg BID |
Primary outcome
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
Time frame: 8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
Time frame: 8 weeks
18 secondary outcomes
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
Time frame: 8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.
Time frame: 8 weeks
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).
Time frame: 8 weeks
Response rate on the HAM-A at Week 1 and Week 8.
Time frame: 8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
Time frame: 8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.
Time frame: 8 weeks
Response rate on the patient-rated PGI-C at Week 8.
Time frame: 8 weeks
The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit).
Time frame: 1 week
Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.
Time frame: 6 weeks
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8.
Time frame: 8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale subscales.
Time frame: 8 weeks
Change from Baseline in CGI-S at Week 8.
Time frame: 8 weeks
Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Time frame: 8 weeks
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.
Time frame: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Time frame: 1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
- 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
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD 0332334 in people with Generalized Anxiety Disorder, run by Pfizer at 43 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2012.