Trial Outcomes & Findings for Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder (NCT NCT00389064)

NCT ID: NCT00389064

Last Updated: 2012-04-04

Results Overview

HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 450 participants
• Primary outcome timeframe: Randomization to Week 9
• Results posted on: 2012-04-04

Participant Flow

International multi-center study, 47 sites recruited between Sept 2006 and Apr 2008

Screening for eligibility and wash-out of restriced medications

Participant milestones

Measure	Quetiapine XR Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo
Overall Study STARTED	223	227
Overall Study COMPLETED	178	168
Overall Study NOT COMPLETED	45	59

Reasons for withdrawal

Measure	Quetiapine XR Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo
Overall Study Adverse Event	11	3
Overall Study Lack of Efficacy	3	14
Overall Study Withdrawal by Subject	17	27
Overall Study Physician Decision	2	2
Overall Study Lost to Follow-up	1	2
Overall Study Protocol Violation	2	0
Overall Study Multiple Reasons	9	11

Baseline Characteristics

Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

Baseline characteristics by cohort

Measure	Quetiapine XR n=223 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=227 Participants	Total n=450 Participants Total of all reporting groups
Age, Customized 66 to 75 years	197 Participants n=5 Participants	195 Participants n=7 Participants	392 Participants n=5 Participants
Age, Customized > 75 years	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	157 Participants n=7 Participants	318 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	70 Participants n=7 Participants	132 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to Week 9

Population: Modified Intent to Treat (MITT) population.

HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	-14.97 units on scale Standard Deviation 7.4 • Interval 7.4 to 0.0	-7.21 units on scale Standard Deviation 7.8 • Interval 7.8 to 0.0

SECONDARY outcome

Timeframe: Randomization to Week 9

Population: In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo).

Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.

Change : percentage at week 9 minus percentage at randomization

Outcome measures

Measure	Quetiapine XR n=211 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=217 Participants
Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score	14.82 Percentage of Maximum Total Score Standard Deviation 12.40 • Interval 12.4 to 0.0	4.94 Percentage of Maximum Total Score Standard Deviation 11.60 • Interval 11.6 to 0.0

SECONDARY outcome

Timeframe: Randomization to Week 9

Population: Modified Intent to Treat (MITT) population.

CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score	-1.76 units on scale Standard Deviation 1.10 • Interval 1.1 to 0.0	-0.59 units on scale Standard Deviation 1.00 • Interval 1.0 to 0.0

SECONDARY outcome

Timeframe: Randomization to Week 9

Population: Modified Intent to Treat (MITT) population.

HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score	-8.88 units on scale Standard Deviation 4.20 • Interval 4.2 to 0.0	-3.81 units on scale Standard Deviation 4.60 • Interval 4.6 to 0.0

SECONDARY outcome

Timeframe: Randomization to Week 9

Population: Modified Intent to Treat (MITT) population.

HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score	-6.05 units on scale Standard Deviation 4.00 • Interval 4.0 to 0.0	-3.37 units on scale Standard Deviation 3.90 • Interval 3.9 to 0.0

SECONDARY outcome

Timeframe: Week 9

HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Hamilton Rating Scale for Anxiety (HAM-A) Response.	152 Number of participants.	54 Number of participants.

SECONDARY outcome

Timeframe: Week 9

Population: Modified Intent to Treat (MITT) population.

HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:

• If HAM-A total score≤7, THEN indicator=1
• If HAM-A total score >7, THEN indicator=0

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission	89 Number of participants.	29 Number of participants.

SECONDARY outcome

Timeframe: Randomization to week 9

Population: Modified Intent to Treat (MITT) population.

MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Change in Montgomery-Asberg Depression Rating Scale (MADRS)	-6.94 units on scale Standard Deviation 4.70 • Interval 4.7 to 0.0	-2.22 units on scale Standard Deviation 4.70 • Interval 4.7 to 0.0

SECONDARY outcome

Timeframe: Randomization to week 9

Population: Modified Intent to Treat (MITT) population.

Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization

Outcome measures

Measure	Quetiapine XR n=222 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=226 Participants
Change in the Visual Analogue Scale (VAS) Measuring Pain	-17.95 mm Standard Deviation 21.80 • Interval 21.8 to 0.0	-6.18 mm Standard Deviation 19.80 • Interval 19.8 to 0.0

SECONDARY outcome

Timeframe: From the start of treatment to last dose plus 30 days

Population: Safety population

Number of patients have at least one adverse event

Outcome measures

Measure	Quetiapine XR n=223 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=227 Participants
Safety and Well Tolerated as Measured in Adverse Event	145.00 Participants	114.00 Participants

SECONDARY outcome

Timeframe: From start of the study teatment to last dose plus 30 days

Population: Safety population

Number of patients have adverse events associated with EPS

Outcome measures

Measure	Quetiapine XR n=223 Participants Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=227 Participants
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)	12.00 Patients	5.00 Patients

Adverse Events

Quetiapine XR

Serious events: 1 serious events

Other events: 171 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Measure	Quetiapine XR n=223 participants at risk Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=227 participants at risk
Infections and infestations Bronchopneumonia	0.45% 1/223	0.00% 0/227
Cardiac disorders Cardiomyopathy	0.00% 0/223	0.44% 1/227
Infections and infestations Cellulitis	0.00% 0/223	0.44% 1/227
Hepatobiliary disorders Cholelithiasis	0.00% 0/223	0.44% 1/227

Other adverse events

Measure	Quetiapine XR n=223 participants at risk Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)	Placebo n=227 participants at risk
Nervous system disorders Dizziness	13.5% 30/223	7.0% 16/227
Gastrointestinal disorders Dry Mouth	16.6% 37/223	7.0% 16/227
Nervous system disorders Headache	11.7% 26/223	12.8% 29/227
Gastrointestinal disorders Nausea	9.0% 20/223	4.0% 9/227
Nervous system disorders Somnolence	26.0% 58/223	8.4% 19/227

Additional Information

Gerard Lynch

AstraZeneca

Email: AZTrial_Results_Posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca
• Publication restrictions are in place

Restriction type: OTHER