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Completed

NCT Number: NCT00715039

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

The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.

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Key information

Conditions

Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lorazepam

Drug

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 names: Ativan

Placebo

Drug

placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine

paroxetine

Drug

20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind

Other names: Paxil

Primary outcomes

  1. 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

Secondary outcomes

  1. CGIC at endpoint (LOCF)

    Time frame: endpoint

  2. PGIC at endpoint (LOCF)

    Time frame: endpoint

  3. Q-LES-Q change from baseline to endpoint (LOCF)

    Time frame: baseline, endpoint

  4. SF-36v2 Mental Health change from baseline to endpoint (LOCF)

    Time frame: baseline, endpoint

  5. HADS-A change from baseline to endpoint (LOCF)

    Time frame: baseline, endpoint

  6. HADS-D change from baseline to endpoint (LOCF)

    Time frame: baseline, endpoint

  7. 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

  8. Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.

    Time frame: baseline and days 2 through 7

  9. DAS-A change from baseline to endpoint (LOCF)

    Time frame: baseline to endpoint

  10. DAS-A 30% and 50% improvement at endpoint;

    Time frame: endpoint

  11. DAS-A 30% sustained improvement beginning at week 1

    Time frame: baseline, week1, 2,4,

  12. HAM-A 30% sustained improvement beginning at week 1

    Time frame: baseline, weeks 1,2,4

  13. HAM-A 30% and 50% improvement at endpoint

    Time frame: endpoint

  14. GA-VAS average change from baseline over the first 6 days

    Time frame: baseline, days 2-7

  15. Change from baseline to daily time point on the GA-VAS(study days 2 through 7)

    Time frame: baseline, days 2-7

  16. GA-VAS change from baseline to endpoint

    Time frame: aseline, endpoint

  17. GA-VAS sustained 30% improvement beginning at week 1

    Time frame: baseline, weeks 1,2,4

  18. GA-VAS 30% and 50% improvement at endpoint

    Time frame: endpoint

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Jul 15, 2008
Registry last updated
Oct 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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