NCT00715039

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
Last Updated

October 3, 2008

Status Verified

October 1, 2008

First QC Date

July 11, 2008

Last Update Submit

October 1, 2008

Conditions

Anxiety Disorders

Keywords

generalized anxiety disorderonset of efficacyDaily Assessment of Symptoms-Anxiety (DAS-A)Methods

Outcome Measures

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.

    baseline, days 2 through 7

Secondary Outcomes (18)

  • CGIC at endpoint (LOCF)

    endpoint

  • PGIC at endpoint (LOCF)

    endpoint

  • Q-LES-Q change from baseline to endpoint (LOCF)

    baseline, endpoint

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

    baseline, endpoint

  • HADS-A change from baseline to endpoint (LOCF)

    baseline, endpoint

  • +13 more secondary outcomes

Study Arms (3)

lorazepam

ACTIVE COMPARATOR
Drug: lorazepam

placebo

PLACEBO COMPARATOR
Drug: placebo

paroxetine

ACTIVE COMPARATOR
Drug: paroxetine

Interventions

lorazepamDRUG

1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days

Also known as: Ativan
lorazepam
placeboDRUG

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

placebo
paroxetineDRUG

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

Also known as: Paxil
paroxetine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

Northridge, California, 91406, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

San Diego, California, 92105, United States

Location

Pfizer Investigational Site

Sherman Oaks, California, 91403, United States

Location

Pfizer Investigational Site

Van Nuys, California, 91406, United States

Location

Pfizer Investigational Site

Casselberry, Florida, 32707, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30328, United States

Location

Pfizer Investigational Site

Marietta, Georgia, 30060, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66209, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87104, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45267-0559, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Interventions

LorazepamParoxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

October 1, 2003

Study Completion

May 1, 2004

Last Updated

October 3, 2008

Record last verified: 2008-10

Locations

US(15)