Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00807937
Collaborator
(none)
369
51
4
5
7.2
1.5
Study Details
Study Description
Brief Summary
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
369 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD)
Study Start Date
:
Dec 1, 2008
Actual Primary Completion Date
:
May 1, 2009
Actual Study Completion Date
:
May 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A AZD7325 5mg twice daily |
Drug: AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
|
| Experimental: B AZD7325 15mg twice daily |
Drug: AZD7325
4 tablets and 1 capsule taken twice a day for 28 days
|
| Active Comparator: C Lorazepam 2mg twice daily |
Drug: Lorazepam
4 tablets and 1 capsule taken twice a day for 28 days
|
| Placebo Comparator: D Placebo |
Drug: Placebo
4 tablets and 1 capsule taken twice a day for 28 days
|
Outcome Measures
Primary Outcome Measures
- Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [Baseline to week 4]
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
Secondary Outcome Measures
- Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score [Baseline to week 4]
HADS-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
- Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score [Baseline to week 4]
The 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
- Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score [Baseline to week 4]
The 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.
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score [Baseline to week 4]
Q-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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Signed informed consent before any study-related procedures start.
-
The patient is previously diagnosed with Generalized Anxiety Disorder.
-
The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.
Exclusion Criteria:
-
Patient has a lifetime history of schizophrenia or other psychotic disorders
-
Patient has a history of seizures or seizure disorder.
-
Patient is pregnant or breast feeding.
-
Patient has received electroconvulsive treatment (ECT) in the past.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Mesa | Arizona | United States | |
| 2 | Research Site | Little Rock | Arkansas | United States | |
| 3 | Research Site | Carson | California | United States | |
| 4 | Research Site | Escondido | California | United States | |
| 5 | Research Site | Glendale | California | United States | |
| 6 | Research Site | Irvine | California | United States | |
| 7 | Research Site | Redlands | California | United States | |
| 8 | Research Site | Riverside | California | United States | |
| 9 | Research Site | Sherman Oaks | California | United States | |
| 10 | Research Site | Fort Lauderdale | Florida | United States | |
| 11 | Research Site | Fort Myers | Florida | United States | |
| 12 | Research Site | Gainsville | Florida | United States | |
| 13 | Research Site | Hallandale Beach | Florida | United States | |
| 14 | Research Site | Jacksonville | Florida | United States | |
| 15 | Research Site | Maitland | Florida | United States | |
| 16 | Research Site | Orlando | Florida | United States | |
| 17 | Research Site | St. Petersburg | Florida | United States | |
| 18 | Research Site | Tampa | Florida | United States | |
| 19 | Research Site | West Palm Beach | Florida | United States | |
| 20 | Research Site | Atlanta | Georgia | United States | |
| 21 | Research Site | Hoffman Estates | Illinois | United States | |
| 22 | Research Site | Oak Brook | Illinois | United States | |
| 23 | Research Site | Schaumburg | Illinois | United States | |
| 24 | Research Site | Lafayette | Indiana | United States | |
| 25 | Research Site | Terre Haute | Indiana | United States | |
| 26 | Research Site | Shreveport | Louisiana | United States | |
| 27 | Research Site | Glen Burnie | Maryland | United States | |
| 28 | Research Site | Westminster | Maryland | United States | |
| 29 | Research Site | Braintree | Massachusetts | United States | |
| 30 | Research Site | Piscataway | New Jersey | United States | |
| 31 | Research Site | Cedarhurst | New York | United States | |
| 32 | Research Site | New York | New York | United States | |
| 33 | Research Site | Staten Island | New York | United States | |
| 34 | Research Site | Raleigh | North Carolina | United States | |
| 35 | Research Site | Cincinnati | Ohio | United States | |
| 36 | Research Site | Cleveland | Ohio | United States | |
| 37 | Research Site | Dayton | Ohio | United States | |
| 38 | Research Site | Willoughby | Ohio | United States | |
| 39 | Research Site | Oklahoma City | Oklahoma | United States | |
| 40 | Research Site | Eugene | Oregon | United States | |
| 41 | Research Site | Salem | Oregon | United States | |
| 42 | Research Site | Allentown | Pennsylvania | United States | |
| 43 | Research Site | Philadelphia | Pennsylvania | United States | |
| 44 | Research Site | Charleston | South Carolina | United States | |
| 45 | Research Site | Bartlett | Tennessee | United States | |
| 46 | Research Site | Austin | Texas | United States | |
| 47 | Research Site | Dallas | Texas | United States | |
| 48 | Research Site | San Antonio | Texas | United States | |
| 49 | Research Site | Wichita Falls | Texas | United States | |
| 50 | Research Site | Richmond | Virginia | United States | |
| 51 | Research Site | Seattle | Washington | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Mark A. Smith, MD, PhD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00807937
Other Study ID Numbers:
- D1140C00014
First Posted:
Dec 15, 2008
Last Update Posted:
Oct 8, 2010
Last Verified:
Sep 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | International multi-center study, 43 sites recruited between Dec 2008 and May 2009 |
|---|---|
| Pre-assignment Detail | Screening for eligibility and wash-out of restriced medications |
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo |
| Period Title: Overall Study | ||||
| STARTED | 93 | 92 | 92 | 92 |
| COMPLETED | 66 | 67 | 78 | 77 |
| NOT COMPLETED | 27 | 25 | 14 | 15 |
Baseline Characteristics
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo | Total of all reporting groups |
| Overall Participants | 93 | 92 | 92 | 92 | 369 |
| Age, Customized (Number) [Number] | |||||
| 18-39 years |
46
49.5%
|
42
45.7%
|
43
46.7%
|
44
47.8%
|
175
47.4%
|
| 40-65 years |
47
50.5%
|
50
54.3%
|
49
53.3%
|
48
52.2%
|
194
52.6%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
58
62.4%
|
43
46.7%
|
45
48.9%
|
45
48.9%
|
191
51.8%
|
| Male |
35
37.6%
|
49
53.3%
|
47
51.1%
|
47
51.1%
|
178
48.2%
|
Outcome Measures
| Title | Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
|---|---|
| Description | 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 |
| Time Frame | Baseline to week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo |
| Measure Participants | 89 | 89 | 91 | 90 |
| Least Squares Mean (Standard Error) [Units on scale] |
-10.1
(0.89)
|
-10.4
(0.89)
|
-10.8
(0.88)
|
-9.5
(0.88)
|
| Title | Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score |
|---|---|
| Description | HADS-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 |
| Time Frame | Baseline to week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo |
| Measure Participants | 89 | 89 | 91 | 90 |
| Least Squares Mean (Standard Error) [Units on scale] |
-5.0
(0.51)
|
-4.9
(0.51)
|
-5.0
(0.51)
|
-4.5
(0.50)
|
| Title | Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score |
|---|---|
| Description | The 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 |
| Time Frame | Baseline to week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo |
| Measure Participants | 89 | 89 | 91 | 90 |
| Least Squares Mean (Standard Error) [Units on scale] |
-5.5
(0.51)
|
-5.7
(0.51)
|
-6.0
(0.51)
|
-5.1
(0.51)
|
| Title | Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score |
|---|---|
| Description | The 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. |
| Time Frame | Baseline to week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo |
| Measure Participants | 89 | 89 | 91 | 90 |
| Least Squares Mean (Standard Error) [Units on scale] |
-4.5
(0.43)
|
-4.7
(0.43)
|
-4.9
(0.43)
|
-4.3
(0.43)
|
| Title | Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score |
|---|---|
| Description | Q-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 |
| Time Frame | Baseline to week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo |
| Measure Participants | 88 | 89 | 91 | 90 |
| Least Squares Mean (Standard Error) [percentage] |
7.79
(1.339)
|
9.04
(1.338)
|
7.46
(1.318)
|
6.95
(1.317)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | ||||
| Arm/Group Description | AZD7325 5 mg twice daily (BID) | AZD7325 15 mg twice daily (BID) | Lorazepam 2 mg twice daily (BID) | Placebo | ||||
All Cause Mortality |
||||||||
| AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/93 (0%) | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 63/93 (67.7%) | 59/92 (64.1%) | 65/92 (70.7%) | 51/92 (55.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 11/93 (11.8%) | 8/92 (8.7%) | 7/92 (7.6%) | 8/92 (8.7%) | ||||
| Diarrhoea | 3/93 (3.2%) | 7/92 (7.6%) | 5/92 (5.4%) | 5/92 (5.4%) | ||||
| Dry Mouth | 4/93 (4.3%) | 5/92 (5.4%) | 6/92 (6.5%) | 3/92 (3.3%) | ||||
| Vomiting | 3/93 (3.2%) | 1/92 (1.1%) | 2/92 (2.2%) | 5/92 (5.4%) | ||||
| General disorders | ||||||||
| Fatigue | 10/93 (10.8%) | 2/92 (2.2%) | 15/92 (16.3%) | 8/92 (8.7%) | ||||
| Feeling Abnormal | 5/93 (5.4%) | 8/92 (8.7%) | 4/92 (4.3%) | 3/92 (3.3%) | ||||
| Feeling Drunk | 5/93 (5.4%) | 4/92 (4.3%) | 5/92 (5.4%) | 0/92 (0%) | ||||
| Infections and infestations | ||||||||
| Upper Respiratory Tract Infection | 2/93 (2.2%) | 5/92 (5.4%) | 1/92 (1.1%) | 6/92 (6.5%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Increased Appetite | 5/93 (5.4%) | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 31/93 (33.3%) | 27/92 (29.3%) | 14/92 (15.2%) | 11/92 (12%) | ||||
| Somnolence | 18/93 (19.4%) | 16/92 (17.4%) | 29/92 (31.5%) | 11/92 (12%) | ||||
| Headache | 8/93 (8.6%) | 8/92 (8.7%) | 11/92 (12%) | 11/92 (12%) | ||||
| Sedation | 3/93 (3.2%) | 6/92 (6.5%) | 7/92 (7.6%) | 1/92 (1.1%) | ||||
| Psychiatric disorders | ||||||||
| Euphoric Mood | 8/93 (8.6%) | 7/92 (7.6%) | 4/92 (4.3%) | 1/92 (1.1%) | ||||
| Anxiety | 5/93 (5.4%) | 3/92 (3.3%) | 1/92 (1.1%) | 1/92 (1.1%) | ||||
| Mood Altered | 5/93 (5.4%) | 4/92 (4.3%) | 0/92 (0%) | 0/92 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Gerard Lynch |
|---|---|
| Organization | AstraZeneca |
| Phone | |
| aztrial_results_posting@astrazeneca.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00807937
Other Study ID Numbers:
- D1140C00014
First Posted:
Dec 15, 2008
Last Update Posted:
Oct 8, 2010
Last Verified:
Sep 1, 2010