Generalized Anxiety Disorder Adjunct Study

A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Anxiety; Anxiety Neuroses; Anxiety States
• Intervention / Treatment: Drug: Placebo; Drug: quetiapine fumarate XR

• Study Type: Interventional
• Enrollment (Actual): 409
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States
      • Research Site
  • California
    • Beverly Hills, California, United States
      • Research Site
    • Encino, California, United States
      • Research Site
    • Fresno, California, United States
      • Research Site
    • La Mesa, California, United States
      • Research Site
    • Oceanside, California, United States
      • Research Site
    • Redlands, California, United States
      • Research Site
    • San Diego, California, United States
      • Research Site
    • San Francisco, California, United States
      • Research Site
    • Sherman Oaks, California, United States
      • Research Site
  • Florida
    • Bradenton, Florida, United States
      • Research Site
    • Dayton, Florida, United States
      • Research Site
    • Hialeah, Florida, United States
      • Research Site
    • Jacksonville, Florida, United States
      • Research Site
    • Maitland, Florida, United States
      • Research Site
    • Miami, Florida, United States
      • Research Site
    • North Miami, Florida, United States
      • Research Site
    • Orlando, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
    • West Palm Beach, Florida, United States
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Research Site
    • Columbus, Georgia, United States
      • Research Site
  • Illinois
    • Chicago, Illinois, United States
      • Research Site
  • Indiana
    • Lafayette, Indiana, United States
      • Research Site
    • Merrillville, Indiana, United States
      • Research Site
    • Terre Haute, Indiana, United States
      • Research Site
  • Kansas
    • Prairie Village, Kansas, United States
      • Research Site
  • Kentucky
    • Owenboro, Kentucky, United States
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States
      • Research Site
  • Maryland
    • Rockville, Maryland, United States
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States
      • Research Site
  • New Jersey
    • Cherry Hill, New Jersey, United States
      • Research Site
    • Clementon, New Jersey, United States
      • Research Site
  • New York
    • Brooklyn, New York, United States
      • Research Site
    • Cedarhurst, New York, United States
      • Research Site
    • Fresh Meadows, New York, United States
      • Research Site
    • New York, New York, United States
      • Research Site
    • Rochester, New York, United States
      • Research Site
    • Staten Island, New York, United States
      • Research Site
  • Ohio
    • Toledo, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Oregon
    • Portland, Oregon, United States
      • Research Site
    • Salem, Oregon, United States
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States
      • Research Site
  • Texas
    • Houston, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site
    • Witchita Falls, Texas, United States
      • Research Site
  • Virginia
    • Richmond, Virginia, United States
      • Research Site
  • Washington
    • Bellevue, Washington, United States
      • Research Site
    • Seattle, Washington, United States
      • Research Site
    • Spokane, Washington, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Provision of Informed Consent

• Documented diagnosis of Generalized Anxiety Disorder
• Female patients must not be pregnant and be willing to use a reliable method of birth control
• Be able to understand and comply with study requirements

Exclusion Criteria:

Other psychiatric disorders that could confound the study results, as judged by the study doctor

• Moderate to severe depression
• Other clinically relevant diseases, as judged by the study doctor
• Medication that you are taking, as judged by the study doctor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Adjunctive Placebo Seroquel XR to anxiety treatment	Drug: Placebo; oral
Experimental: 2; Adjunctive Seroquel XR to anxiety treatment	Drug: quetiapine fumarate XR; oral; Other Names: Seroquel XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.	Baseline (randomization) and then 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score	The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1). Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8	This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'. Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score	The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score	The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively). Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8	Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8	Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score	The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer. Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score	Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score	Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score	Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score	Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score	Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in CGI-S Score	Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1	Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.	Baseline (randomization) and then 8 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2014 Feb;26(1):3-18.
• Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2013 Nov;25(4):E7-22.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 24, 2007
• First Submitted That Met QC Criteria: September 24, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Estimate): April 14, 2011
• Last Update Submitted That Met QC Criteria: April 12, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: anxiety; anxiety disorder; Generalized anxiety disorders; adjunct treatment in anxiety; partial or non-responder in anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: D1441L00016