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Completed

NCT Number: NCT00534599

Generalized Anxiety Disorder Adjunct Study

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

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Key information

Conditions

Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

oral

Quetiapine Fumarate XR

Drug

oral

Other names: Seroquel XR

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2007
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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