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Generalized Anxiety Disorder Adjunct Study

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ClinicalTrials.gov Identifier: NCT00534599
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : April 5, 2011
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States Drug: Placebo Drug: quetiapine fumarate XR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

    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 :
  1. 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 ]

    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.


  2. 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 ]

    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.


  3. Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]
    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.

  4. Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

    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.


  5. Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ]
    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.

  6. Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ]
    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.

  7. 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 ]

    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.


  8. 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 ]
    Results based on MITT population with available data for this outcome measure.

  9. 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 ]
    Results based on MITT population with available data for this outcome measure.

  10. Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

    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.


  11. Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]
    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.

  12. Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

    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.


  13. Least Square Mean Change From Randomization to Week 1 in CGI-S Score [ Time Frame: Baseline (randomization) and then 8 weeks ]
    Results based on MITT population with available data for this outcome measure.

  14. Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 [ Time Frame: Baseline (randomization) and then 8 weeks ]

    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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534599


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Martin Brecher, MD AstraZeneca

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
First Posted: September 26, 2007    Key Record Dates
Results First Posted: April 5, 2011
Last Update Posted: April 14, 2011
Last Verified: April 2011

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

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