Generalized Anxiety DisorderPhase 2NCT00921063
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
A Phase 2 study testing PD 0332334 and Alprazolam extended release in people with Generalized Anxiety Disorder, run by Pfizer.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population 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 and Alprazolam extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jul 2006
- Phase
- Phase 2
- 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
- Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
- HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.
Who cannot join
- Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
- Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
- Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population
- Conditions
- Generalized Anxiety Disorder
- Being tested
- PD 0332334, placebo, Alprazolam extended release
- 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
250 mg capsule, BID for 4 weeks
PD 0332334Drug
100 mg capsule, BID for 4 weeks
placeboDrug
0 mg capsule, BID for 4 weeks
Alprazolam extended releaseDrug
Also called Xanax XR
1 mg capsule, BID for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PD 0332334 250 mg | Experimental | Not described Receives: Drug: PD 0332334 |
| PD 0332334 100 mg | Experimental | Not described Receives: Drug: PD 0332334 |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Alprazolam extended release | Active comparator | Not described Receives: Drug: Alprazolam extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-A Total Score
Measured: 4 weeks
Secondary outcomes (9)
HAM-A total score at week 1, 2 and 4
Measured: 1. 2. ands 4 weeks
HAM-A somatic and psychic subscales
Measured: 1, 2, and 4 weeks
HAM-A responders
Measured: 4 weeks
HAM-A sustained responders
Measured: Week 1 through week 4
DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
Measured: Day 2 through day 7
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
Measured: 1 and 4 weeks
HAM-D total score
Measured: 1 and 4 weeks
Sheehan Disability Score (SDS)
Measured: 4 weeks
Treatment Satisfaction Questionaire for Medication
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionJul 2006
- Study completionJul 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921063
- Sponsor's protocol ID
- A5361007
- Status last verified
- Feb 2010
- First submitted
- 15 Jun 2009
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00921063
- Acronym / sponsor ID
- A5361007
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Jun 2009 (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.
The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD 0332334 250 mg | Experimental | Drug: PD 0332334 |
| PD 0332334 100 mg | Experimental | Drug: PD 0332334 |
| placebo | Placebo comparator | Drug: placebo |
| Alprazolam extended release | Active comparator | Drug: Alprazolam extended release |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
- HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.
Key exclusion criteria (3 listed)
- Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
- Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
- Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
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: imagabalin250 mg capsule, BID for 4 weeks | Drug | PD 0332334 250 mg |
| PD 0332334100 mg capsule, BID for 4 weeks | Drug | PD 0332334 100 mg |
| placebo0 mg capsule, BID for 4 weeks | Drug | placebo |
| Alprazolam extended releaseAlso: Xanax XR1 mg capsule, BID for 4 weeks | Drug | Alprazolam extended release |
Primary outcome
HAM-A Total Score
Time frame: 4 weeks
9 secondary outcomes
HAM-A total score at week 1, 2 and 4
Time frame: 1. 2. ands 4 weeks
HAM-A somatic and psychic subscales
Time frame: 1, 2, and 4 weeks
HAM-A responders
Time frame: 4 weeks
HAM-A sustained responders
Time frame: Week 1 through week 4
DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
Time frame: Day 2 through day 7
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
Time frame: 1 and 4 weeks
HAM-D total score
Time frame: 1 and 4 weeks
Sheehan Disability Score (SDS)
Time frame: 4 weeks
Treatment Satisfaction Questionaire for Medication
Time frame: 4 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 19 Feb 2010.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD 0332334 and Alprazolam extended release in people with Generalized Anxiety Disorder, run by Pfizer.
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 3 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 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
HAM-A Total Score (time frame: 4 weeks). 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 19 Feb 2010.