Anxiety DisordersNCT00715039
Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
A study testing lorazepam and paroxetine in people with Anxiety Disorders, run by Pfizer at 15 sites in United States.
Trial summary
The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- lorazepam and paroxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2003to May 2004
- Phase
- Interventional
- 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
- Primary Diagnosis of GAD (DSM IV, 300.02) as established by the clinician using all sources of data including the MINI structured interview
- HAM A score ³20 at the Screening (Study Day -7) and Baseline (Study Day 1) Visits by observer rating
- Good health as determined by medical history, physical examination, vital signs, electrocardiography (ECG), and clinical laboratory measurements
- Covi Anxiety Scale total score ³9 and Raskin Depression Scale total score £7 at the Screening Visit (to ensure predominance of anxiety symptoms over depression symptoms)
- Age 18 to 65 (inclusive)
Who cannot join
- Patients with most other current DSM-IV Axis I disorders.
- Patients with current or past schizophrenia, Psychotic disorder
- Delirium, dementia, amnestic, and other clinically significant cognitive disorders
- Bipolar or schizoaffective disorder
- Benzodiazepine abuse or dependence; and/or Factitious disorder.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, 87104
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Casselberry, Florida, 32707
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Northridge, California, 91406
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Overland Park, Kansas, 66209
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
San Diego, California, 92105
Pfizer Investigational Site
Sherman Oaks, California, 91403
Pfizer Investigational Site
Van Nuys, California, 91406
About this study
Official title: A 4-Week, Double-Blind, Randomized, Multicenter, Fixed Dose, Placebo-Controlled, Parallel Group Study of Lorazepam and Paroxetine in Patients With Generalized Anxiety Disorder: Assessment of a New Instrument Intended to Capture Rapid Onset
The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
- Conditions
- Anxiety Disorders
- Being tested
- lorazepam, placebo, paroxetine
- Keywords
- generalized anxiety disorder, onset of efficacy, Daily Assessment of Symptoms-Anxiety (DAS-A), Methods
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorazepamDrug
Also called Ativan
1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
placeboDrug
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
paroxetineDrug
Also called Paxil
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
| Study group | Role | What they receive |
|---|---|---|
| lorazepam | Active comparator | Not described Receives: Drug: lorazepam |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| paroxetine | Active comparator | Not described Receives: Drug: paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire.
Measured: baseline, days 2 through 7
Secondary outcomes (18)
CGIC at endpoint (LOCF)
Measured: endpoint
PGIC at endpoint (LOCF)
Measured: endpoint
Q-LES-Q change from baseline to endpoint (LOCF)
Measured: baseline, endpoint
SF-36v2 Mental Health change from baseline to endpoint (LOCF)
Measured: baseline, endpoint
HADS-A change from baseline to endpoint (LOCF)
Measured: baseline, endpoint
HADS-D change from baseline to endpoint (LOCF)
Measured: baseline, endpoint
Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.
Measured: baseline and weeks 1,2,4, and 5
Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.
Measured: baseline and days 2 through 7
DAS-A change from baseline to endpoint (LOCF)
Measured: baseline to endpoint
DAS-A 30% and 50% improvement at endpoint;
Measured: endpoint
DAS-A 30% sustained improvement beginning at week 1
Measured: baseline, week1, 2,4,
HAM-A 30% sustained improvement beginning at week 1
Measured: baseline, weeks 1,2,4
HAM-A 30% and 50% improvement at endpoint
Measured: endpoint
GA-VAS average change from baseline over the first 6 days
Measured: baseline, days 2-7
Change from baseline to daily time point on the GA-VAS(study days 2 through 7)
Measured: baseline, days 2-7
GA-VAS change from baseline to endpoint
Measured: aseline, endpoint
GA-VAS sustained 30% improvement beginning at week 1
Measured: baseline, weeks 1,2,4
GA-VAS 30% and 50% improvement at endpoint
Measured: endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startOct 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 169 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
- NCT00715039
- Sponsor's protocol ID
- A9001141
- Status last verified
- Oct 2008
- First submitted
- 11 Jul 2008
- Last updated
- 3 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Double-Blind, Randomized, Multicenter, Fixed Dose, Placebo-Controlled, Parallel Group Study of Lorazepam and Paroxetine in Patients With Generalized Anxiety Disorder: Assessment of a New Instrument Intended to Capture Rapid Onset
- ClinicalTrials.gov ID
- NCT00715039
- Acronym / sponsor ID
- A9001141
- Conditions
- Anxiety Disorders
- Keywords
- generalized anxiety disorder, onset of efficacy, Daily Assessment of Symptoms-Anxiety (DAS-A), Methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- May 2004 (actual)
- First posted
- 15 Jul 2008 (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 study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lorazepam | Active comparator | Drug: lorazepam |
| placebo | Placebo comparator | Drug: placebo |
| paroxetine | Active comparator | Drug: paroxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary Diagnosis of GAD (DSM IV, 300.02) as established by the clinician using all sources of data including the MINI structured interview
- HAM A score ³20 at the Screening (Study Day -7) and Baseline (Study Day 1) Visits by observer rating
- Good health as determined by medical history, physical examination, vital signs, electrocardiography (ECG), and clinical laboratory measurements
- Covi Anxiety Scale total score ³9 and Raskin Depression Scale total score £7 at the Screening Visit (to ensure predominance of anxiety symptoms over depression symptoms)
- Age 18 to 65 (inclusive)
Key exclusion criteria (5 listed)
- Patients with most other current DSM-IV Axis I disorders.
- Patients with current or past schizophrenia, Psychotic disorder
- Delirium, dementia, amnestic, and other clinically significant cognitive disorders
- Bipolar or schizoaffective disorder
- Benzodiazepine abuse or dependence; and/or Factitious disorder.
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 |
|---|---|---|
| lorazepamAlso: Ativan1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days | Drug | lorazepam |
| placeboplacebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine | Drug | placebo |
| paroxetineAlso: Paxil20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind | Drug | paroxetine |
Primary outcome
Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire.
Time frame: baseline, days 2 through 7
18 secondary outcomes
CGIC at endpoint (LOCF)
Time frame: endpoint
PGIC at endpoint (LOCF)
Time frame: endpoint
Q-LES-Q change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
SF-36v2 Mental Health change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
HADS-A change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
HADS-D change from baseline to endpoint (LOCF)
Time frame: baseline, endpoint
Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.
Time frame: baseline and weeks 1,2,4, and 5
Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.
Time frame: baseline and days 2 through 7
DAS-A change from baseline to endpoint (LOCF)
Time frame: baseline to endpoint
DAS-A 30% and 50% improvement at endpoint;
Time frame: endpoint
DAS-A 30% sustained improvement beginning at week 1
Time frame: baseline, week1, 2,4,
HAM-A 30% sustained improvement beginning at week 1
Time frame: baseline, weeks 1,2,4
HAM-A 30% and 50% improvement at endpoint
Time frame: endpoint
GA-VAS average change from baseline over the first 6 days
Time frame: baseline, days 2-7
Change from baseline to daily time point on the GA-VAS(study days 2 through 7)
Time frame: baseline, days 2-7
GA-VAS change from baseline to endpoint
Time frame: aseline, endpoint
GA-VAS sustained 30% improvement beginning at week 1
Time frame: baseline, weeks 1,2,4
GA-VAS 30% and 50% improvement at endpoint
Time frame: endpoint
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 3 Oct 2008.
- 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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lorazepam and paroxetine in people with Anxiety Disorders, run by Pfizer at 15 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 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 3 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
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?
Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire. (time frame: baseline, days 2 through 7). 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 3 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.