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Generalized Anxiety Disorder Adjunct Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00534599
First received: September 24, 2007
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Anxiety
Anxiety Disorders
Anxiety Neuroses
Anxiety States
Drug: Placebo
Drug: quetiapine fumarate XR
Phase 3

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 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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.


  • Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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.


  • Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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.


  • Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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.


  • Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    Results based on MITT population with available data for this outcome measure.

  • Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    Results based on MITT population with available data for this outcome measure.

  • Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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 Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    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 Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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 Change From Randomization to Week 1 in CGI-S Score [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]
    Results based on MITT population with available data for this outcome measure.

  • Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 [ Time Frame: Baseline (randomization) and then 8 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 409
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Seroquel XR

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534599

  Show 53 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Martin Brecher, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00534599     History of Changes
Other Study ID Numbers: D1441L00016
Study First Received: September 24, 2007
Results First Received: August 13, 2009
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Generalized anxiety disorders
anxiety
adjunct treatment in anxiety
anxiety disorder
partial or non-responder in anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014