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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
Contact
1-800-718-1021
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.

NCT00715039
Pfizer
Completed
Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

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Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Anxiety Disorders
  • 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
  • Active Comparator: lorazepam
    Intervention: Drug: lorazepam
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: paroxetine
    Intervention: Drug: paroxetine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
May 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00715039
A9001141
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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