AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD) - Full Text View

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:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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 May 22, 2013