Trial Outcomes & Findings for Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325 (NCT NCT00807937)
NCT ID: NCT00807937
Last Updated: 2010-10-08
Results Overview
HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
369 participants
Primary outcome timeframe
Baseline to week 4
Results posted on
2010-10-08
Participant Flow
International multi-center study, 43 sites recruited between Dec 2008 and May 2009
Screening for eligibility and wash-out of restriced medications
Participant milestones
| Measure |
AZD7325 5 mg
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
AZD7325 15 mg twice daily (BID)
|
Lorazepam
Lorazepam 2 mg twice daily (BID)
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
93
|
92
|
92
|
92
|
|
Overall Study
COMPLETED
|
66
|
67
|
78
|
77
|
|
Overall Study
NOT COMPLETED
|
27
|
25
|
14
|
15
|
Reasons for withdrawal
| Measure |
AZD7325 5 mg
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
AZD7325 15 mg twice daily (BID)
|
Lorazepam
Lorazepam 2 mg twice daily (BID)
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
12
|
5
|
4
|
|
Overall Study
Protocol Violation
|
4
|
5
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
2
|
|
Overall Study
Intake of prohibited medicine
|
0
|
0
|
2
|
0
|
|
Overall Study
All other reasons (not provided)
|
2
|
4
|
0
|
1
|
Baseline Characteristics
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Baseline characteristics by cohort
| Measure |
AZD7325 5 mg
n=93 Participants
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=92 Participants
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=92 Participants
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=92 Participants
Placebo
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-39 years
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Age, Customized
40-65 years
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
178 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 4HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization
Outcome measures
| Measure |
AZD7325 5 mg
n=89 Participants
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=89 Participants
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=91 Participants
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=90 Participants
Placebo
|
|---|---|---|---|---|
|
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
-10.1 Units on scale
Standard Error 0.89 • Interval 0.89 to
|
-10.4 Units on scale
Standard Error 0.89 • Interval 0.89 to
|
-10.8 Units on scale
Standard Error 0.88 • Interval 0.88 to
|
-9.5 Units on scale
Standard Error 0.88 • Interval 0.88 to
|
SECONDARY outcome
Timeframe: Baseline to week 4HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization
Outcome measures
| Measure |
AZD7325 5 mg
n=89 Participants
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=89 Participants
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=91 Participants
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=90 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
|
-5.0 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
-4.9 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
-5.0 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
-4.5 Units on scale
Standard Error 0.50 • Interval 0.5 to
|
SECONDARY outcome
Timeframe: Baseline to week 4The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder. Change: score at week 4 minus score at randomization
Outcome measures
| Measure |
AZD7325 5 mg
n=89 Participants
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=89 Participants
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=91 Participants
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=90 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
|
-5.5 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
-5.7 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
-6.0 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
-5.1 Units on scale
Standard Error 0.51 • Interval 0.51 to
|
SECONDARY outcome
Timeframe: Baseline to week 4The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.
Outcome measures
| Measure |
AZD7325 5 mg
n=89 Participants
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=89 Participants
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=91 Participants
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=90 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
|
-4.5 Units on scale
Standard Error 0.43 • Interval 0.43 to
|
-4.7 Units on scale
Standard Error 0.43 • Interval 0.43 to
|
-4.9 Units on scale
Standard Error 0.43 • Interval 0.43 to
|
-4.3 Units on scale
Standard Error 0.43 • Interval 0.43 to
|
SECONDARY outcome
Timeframe: Baseline to week 4Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction. Change : percentage at week 4 minus percentage at randomization
Outcome measures
| Measure |
AZD7325 5 mg
n=88 Participants
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=89 Participants
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=91 Participants
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=90 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
|
7.79 percentage
Standard Error 1.339 • Interval 1.339 to
|
9.04 percentage
Standard Error 1.338 • Interval 1.338 to
|
7.46 percentage
Standard Error 1.318
|
6.95 percentage
Standard Error 1.317 • Interval 1.317 to
|
Adverse Events
AZD7325 5 mg
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
AZD7325 15 mg
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Lorazepam
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD7325 5 mg
n=93 participants at risk
AZD7325 5 mg twice daily (BID)
|
AZD7325 15 mg
n=92 participants at risk
AZD7325 15 mg twice daily (BID)
|
Lorazepam
n=92 participants at risk
Lorazepam 2 mg twice daily (BID)
|
Placebo
n=92 participants at risk
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.8%
11/93
|
8.7%
8/92
|
7.6%
7/92
|
8.7%
8/92
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
3/93
|
7.6%
7/92
|
5.4%
5/92
|
5.4%
5/92
|
|
Gastrointestinal disorders
Dry Mouth
|
4.3%
4/93
|
5.4%
5/92
|
6.5%
6/92
|
3.3%
3/92
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
3/93
|
1.1%
1/92
|
2.2%
2/92
|
5.4%
5/92
|
|
General disorders
Fatigue
|
10.8%
10/93
|
2.2%
2/92
|
16.3%
15/92
|
8.7%
8/92
|
|
General disorders
Feeling Abnormal
|
5.4%
5/93
|
8.7%
8/92
|
4.3%
4/92
|
3.3%
3/92
|
|
General disorders
Feeling Drunk
|
5.4%
5/93
|
4.3%
4/92
|
5.4%
5/92
|
0.00%
0/92
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.2%
2/93
|
5.4%
5/92
|
1.1%
1/92
|
6.5%
6/92
|
|
Metabolism and nutrition disorders
Increased Appetite
|
5.4%
5/93
|
0.00%
0/92
|
0.00%
0/92
|
0.00%
0/92
|
|
Nervous system disorders
Dizziness
|
33.3%
31/93
|
29.3%
27/92
|
15.2%
14/92
|
12.0%
11/92
|
|
Nervous system disorders
Somnolence
|
19.4%
18/93
|
17.4%
16/92
|
31.5%
29/92
|
12.0%
11/92
|
|
Nervous system disorders
Headache
|
8.6%
8/93
|
8.7%
8/92
|
12.0%
11/92
|
12.0%
11/92
|
|
Nervous system disorders
Sedation
|
3.2%
3/93
|
6.5%
6/92
|
7.6%
7/92
|
1.1%
1/92
|
|
Psychiatric disorders
Euphoric Mood
|
8.6%
8/93
|
7.6%
7/92
|
4.3%
4/92
|
1.1%
1/92
|
|
Psychiatric disorders
Anxiety
|
5.4%
5/93
|
3.3%
3/92
|
1.1%
1/92
|
1.1%
1/92
|
|
Psychiatric disorders
Mood Altered
|
5.4%
5/93
|
4.3%
4/92
|
0.00%
0/92
|
0.00%
0/92
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER