Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

NCT00715039

Last updated date
Study Location
Pfizer Investigational Site
Glendale, California, 91206, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anxiety Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Anxiety DisordersClinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
NCT00715039
  1. Glendale, California
  2. Northridge, California
  3. Orange, California
  4. San Diego, California
  5. Sherman Oaks, California
  6. Van Nuys, California
  7. Casselberry, Florida
  8. Orlando, Florida
  9. Atlanta, Georgia
  10. Marietta, Georgia
  11. Overland Park, Kansas
  12. Overland Park, Kansas
  13. Albuquerque, New Mexico
  14. Albuquerque, New Mexico
  15. Cincinnati, Ohio
ALL GENDERS
18 Years+
years
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Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
Official Title  ICMJE 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
Brief Summary The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Drug: lorazepam
    1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
    Other Name: Ativan
  • Drug: placebo
    placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
  • Drug: paroxetine
    20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
    Other Name: Paxil
Study Arms  ICMJE
  • Active Comparator: lorazepam
    Intervention: Drug: lorazepam
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: paroxetine
    Intervention: Drug: paroxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2008)
169
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00715039
Other Study ID Numbers  ICMJE A9001141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP