Trial Outcomes & Findings for AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD) (NCT NCT00808249)
NCT ID: NCT00808249
Last Updated: 2011-06-20
Results Overview
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
725 participants
Primary outcome timeframe
From randomization (baseline) to week 4
Results posted on
2011-06-20
Participant Flow
International multi-center study, 44 sites recruited between Dec 2008 and May 2009
Screening for eligibility and wash-out of restriced medications. 725 subjects enrolled but 424 subjects were randomized. Number of participants analyzed is the number of subjects in MITT (modified intent to treat) population, it is different with any of population listed in the participant flow chart.
Participant milestones
| Measure |
A-AZD7325 2 mg
AZD7325 2 mg BID
|
B-AZD7325 5 mg
AZD7325 5 mg BID
|
C-AZD7325 10 mg
AZD7325 10 mg QD
|
D-Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
107
|
106
|
105
|
106
|
|
Overall Study
COMPLETED
|
90
|
91
|
83
|
90
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
22
|
16
|
Reasons for withdrawal
| Measure |
A-AZD7325 2 mg
AZD7325 2 mg BID
|
B-AZD7325 5 mg
AZD7325 5 mg BID
|
C-AZD7325 10 mg
AZD7325 10 mg QD
|
D-Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
7
|
10
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
2
|
4
|
|
Overall Study
Protocol Violation
|
3
|
3
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
0
|
|
Overall Study
study specific discontinuation criteria
|
1
|
0
|
1
|
0
|
|
Overall Study
All other reasons
|
2
|
1
|
3
|
1
|
Baseline Characteristics
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
Baseline characteristics by cohort
| Measure |
A-AZD7325 2 mg
n=107 Participants
AZD7325 2 mg BID
|
B-AZD7325 5 mg
n=106 Participants
AZD7325 5 mg BID
|
C-AZD7325 10 mg
n=105 Participants
AZD7325 10 mg QD
|
D-Placebo
n=106 Participants
Placebo
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-39
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
188 Participants
n=21 Participants
|
|
Age, Customized
40-65
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From randomization (baseline) to week 4The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
Outcome measures
| Measure |
A-AZD7325 2 mg
n=105 Participants
AZD7325 2 mg BID
|
B-AZD7325 5 mg
n=105 Participants
AZD7325 5 mg BID
|
C-AZD7325 10 mg
n=103 Participants
AZD7325 10 mg QD
|
D-Placebo
n=102 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
-10.9 Units on scale
Standard Error 0.87 • Interval 0.87 to
|
-11.1 Units on scale
Standard Error 0.86 • Interval 0.86 to
|
-11.5 Units on scale
Standard Error 0.87 • Interval 0.87 to
|
-10.9 Units on scale
Standard Error 0.88 • Interval 0.88 to
|
SECONDARY outcome
Timeframe: From randomization (baseline) to week 4The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.
Outcome measures
| Measure |
A-AZD7325 2 mg
n=105 Participants
AZD7325 2 mg BID
|
B-AZD7325 5 mg
n=105 Participants
AZD7325 5 mg BID
|
C-AZD7325 10 mg
n=103 Participants
AZD7325 10 mg QD
|
D-Placebo
n=102 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
|
-4.5 Units on scale
Standard Error 0.49 • Interval 0.49 to
|
-4.2 Units on scale
Standard Error 0.49 • Interval 0.49 to
|
-5.2 Units on scale
Standard Error 0.50 • Interval 0.5 to
|
-4.6 Units on scale
Standard Error 0.50 • Interval 0.5 to
|
SECONDARY outcome
Timeframe: From baseline (randomization) to week 4The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.
Outcome measures
| Measure |
A-AZD7325 2 mg
n=105 Participants
AZD7325 2 mg BID
|
B-AZD7325 5 mg
n=105 Participants
AZD7325 5 mg BID
|
C-AZD7325 10 mg
n=103 Participants
AZD7325 10 mg QD
|
D-Placebo
n=102 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
|
-5.9 Unit on scale
Standard Error 0.51 • Interval 0.51 to
|
-5.8 Unit on scale
Standard Error 0.51 • Interval 0.51 to
|
-6.5 Unit on scale
Standard Error 0.52 • Interval 0.52 to
|
-5.8 Unit on scale
Standard Error 0.52 • Interval 0.52 to
|
SECONDARY outcome
Timeframe: From baseline ( randomization) to week 4The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms
Outcome measures
| Measure |
A-AZD7325 2 mg
n=105 Participants
AZD7325 2 mg BID
|
B-AZD7325 5 mg
n=105 Participants
AZD7325 5 mg BID
|
C-AZD7325 10 mg
n=103 Participants
AZD7325 10 mg QD
|
D-Placebo
n=102 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
|
-5.0 Units on scale
Standard Error 0.41 • Interval 0.41 to
|
-5.3 Units on scale
Standard Error 0.41 • Interval 0.41 to
|
-5.1 Units on scale
Standard Error 0.42 • Interval 0.42 to
|
-5.2 Units on scale
Standard Error 0.42 • Interval 0.42 to
|
SECONDARY outcome
Timeframe: From baseline ( randomization) to week 4The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)
Outcome measures
| Measure |
A-AZD7325 2 mg
n=81 Participants
AZD7325 2 mg BID
|
B-AZD7325 5 mg
n=78 Participants
AZD7325 5 mg BID
|
C-AZD7325 10 mg
n=75 Participants
AZD7325 10 mg QD
|
D-Placebo
n=81 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Sheehan Disability Scale (SDS) Global Total Score
|
-4.7 Units on scale
Standard Error 0.79 • Interval 0.79 to
|
-5.7 Units on scale
Standard Error 0.80 • Interval 0.8 to
|
-6.8 Units on scale
Standard Error 0.82 • Interval 0.82 to
|
-6.8 Units on scale
Standard Error 0.79 • Interval 0.79 to
|
Adverse Events
A-AZD7325 2 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
B-AZD7325 5 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
C-AZD7325 10 mg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
D-Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A-AZD7325 2 mg
AZD7325 2 mg BID
|
B-AZD7325 5 mg
AZD7325 5 mg BID
|
C-AZD7325 10 mg
AZD7325 10 mg QD
|
D-Placebo
Placebo
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.94%
1/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.94%
1/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Psychiatric disorders
Anxiety
|
0.94%
1/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.94%
1/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
Other adverse events
| Measure |
A-AZD7325 2 mg
AZD7325 2 mg BID
|
B-AZD7325 5 mg
AZD7325 5 mg BID
|
C-AZD7325 10 mg
AZD7325 10 mg QD
|
D-Placebo
Placebo
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
12.3%
13/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
17.0%
18/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
30.5%
32/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
11.4%
12/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Nervous system disorders
Headache
|
7.5%
8/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
16.0%
17/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
8.6%
9/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
13.3%
14/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Nervous system disorders
Sedation
|
4.7%
5/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
5.7%
6/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
9.5%
10/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.95%
1/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Nervous system disorders
Somnolence
|
12.3%
13/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
8.5%
9/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
16.2%
17/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
5.7%
6/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Psychiatric disorders
Euphoric Mood
|
6.6%
7/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
10.4%
11/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
9.5%
10/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
5.7%
6/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Psychiatric disorders
Insomnia
|
3.8%
4/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
4.7%
5/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
1.9%
2/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
6.7%
7/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.7%
6/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
3.8%
4/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
10.5%
11/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
6.7%
7/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
General disorders
Fatigue
|
7.5%
8/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
6.6%
7/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
4.8%
5/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
2.9%
3/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
General disorders
Feeling Abnormal
|
0.94%
1/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
3.8%
4/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
7.6%
8/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
0.00%
0/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
10/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
8.5%
9/106
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
9.5%
10/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
7.6%
8/105
Number at risk is number of patients in safety population. The participant flow shows patients randomized and completed the study. The numbers are not the same since 2 patients were randomized but did not take study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER