AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00808249
First received: December 12, 2008
Last updated: June 15, 2011
Last verified: April 2011
  Purpose

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.


Condition Intervention Phase
Anxiety Disorders
Drug: AZD7325
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: From randomization (baseline) to week 4 ] [ Designated as safety issue: No ]
    The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.


Secondary Outcome Measures:
  • Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score [ Time Frame: From randomization (baseline) to week 4 ] [ Designated as safety issue: No ]
    The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.

  • Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score [ Time Frame: From baseline (randomization) to week 4 ] [ Designated as safety issue: No ]
    The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.

  • Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score [ Time Frame: From baseline ( randomization) to week 4 ] [ Designated as safety issue: No ]
    The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms

  • Change in Sheehan Disability Scale (SDS) Global Total Score [ Time Frame: From baseline ( randomization) to week 4 ] [ Designated as safety issue: No ]
    The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)


Enrollment: 725
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-AZD7325 2mg
AZD7325 2mg BID
Drug: AZD7325
2 tablets taken twice a day for 28 days
Experimental: B-AZD7325 5mg
AZD7325 5mg BID
Drug: AZD7325
2 tablets taken twice a day for 28 days
Experimental: C-AZD7325 10mg
AZD7325 10mg QD
Drug: AZD7325
2 tablets taken twice a day for 28 days
Experimental: D-Placebo
Placebo
Drug: Placebo
2 tablets taken twice a day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent before any study-related procedures start.
  • The patient is previously diagnosed with Generalized Anxiety Disorder.
  • The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

Exclusion Criteria:

  • Patient has a lifetime history of schizophrenia or other psychotic disorders
  • Patient has a history of seizures or seizure disorder.
  • Patient is pregnant or breast feeding.
  • Patient has received electroconvulsive treatment (ECT) in the past.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808249

  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark A. Smith, MD, PhD AstraZeneca
Principal Investigator: David V. Sheehan University of South Florida College of Medicine
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD PhD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00808249     History of Changes
Other Study ID Numbers: D1140C00006
Study First Received: December 12, 2008
Results First Received: January 28, 2011
Last Updated: June 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Generalized Anxiety Disorder
GAD
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014