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

NCT00807937 | Completed Phase 2 Results

• 1 other identifier: D1140C00014
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 51

Brief Summary

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.

Conditions

Anxiety Disorders

Keywords

Generalized Anxiety Disorder; GAD; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

  HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization

  Baseline to week 4

Secondary Outcomes (4)

• Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score

  Baseline to week 4

• Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score

  Baseline to week 4

• Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score

  Baseline to week 4

• Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score

  Baseline to week 4

Study Arms (4)

A

EXPERIMENTAL

AZD7325 5mg twice daily

Drug: AZD7325

B

EXPERIMENTAL

AZD7325 15mg twice daily

Drug: AZD7325

C

ACTIVE COMPARATOR

Lorazepam 2mg twice daily

Drug: Lorazepam

D

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD7325 DRUG

4 tablets and 1 capsule taken twice a day for 28 days

A

Lorazepam DRUG

4 tablets and 1 capsule taken twice a day for 28 days

C

Placebo DRUG

4 tablets and 1 capsule taken twice a day for 28 days

D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (51)

Research Site

Mesa, Arizona, United States

Location

Research Site

Little Rock, Arkansas, United States

Location

Research Site

Carson, California, United States

Location

Research Site

Escondido, California, United States

Location

Research Site

Glendale, California, United States

Location

Research Site

Irvine, California, United States

Location

Research Site

Redlands, California, United States

Location

Research Site

Riverside, California, United States

Location

Research Site

Sherman Oaks, California, United States

Location

Research Site

Fort Lauderdale, Florida, United States

Location

Research Site

Fort Myers, Florida, United States

Location

Research Site

Gainsville, Florida, United States

Location

Research Site

Hallandale, Florida, United States

Location

Research Site

Jacksonville, Florida, United States

Location

Research Site

Maitland, Florida, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

St. Petersburg, Florida, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

West Palm Beach, Florida, United States

Location

Research Site

Atlanta, Georgia, United States

Location

Research Site

Hoffman Estates, Illinois, United States

Location

Research Site

Oak Brook, Illinois, United States

Location

Research Site

Schaumburg, Illinois, United States

Location

Research Site

Lafayette, Indiana, United States

Location

Research Site

Terre Haute, Indiana, United States

Location

Research Site

Shreveport, Louisiana, United States

Location

Research Site

Glen Burnie, Maryland, United States

Location

Research Site

Westminster, Maryland, United States

Location

Research Site

Braintree, Massachusetts, United States

Location

Research Site

Piscataway, New Jersey, United States

Location

Research Site

Cedarhurst, New York, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Staten Island, New York, United States

Location

Research Site

Raleigh, North Carolina, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Dayton, Ohio, United States

Location

Research Site

Willoughby, Ohio, United States

Location

Research Site

Oklahoma City, Oklahoma, United States

Location

Research Site

Eugene, Oregon, United States

Location

Research Site

Salem, Oregon, United States

Location

Research Site

Allentown, Pennsylvania, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Charleston, South Carolina, United States

Location

Research Site

Bartlett, Tennessee, United States

Location

Research Site

Austin, Texas, United States

Location

Research Site

Dallas, Texas, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Wichita Falls, Texas, United States

Location

Research Site

Richmond, Virginia, United States

Location

Research Site

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Interventions

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide; Lorazepam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Mark A. Smith, MD, PhD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 8, 2010
• Results First Posted: October 8, 2010

Record last verified: 2010-09

Locations

US (51)