Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00807937
First received: December 12, 2008
Last updated: September 16, 2010
Last verified: September 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders |
Drug: AZD7325 Drug: Lorazepam Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
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
| Enrollment: | 369 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807937
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| United States, Arizona | |
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| Mesa, Arizona, United States | |
| United States, Arkansas | |
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| Charleston, South Carolina, United States | |
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| Bartlett, Tennessee, United States | |
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| Wichita Falls, Texas, United States | |
| United States, Virginia | |
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| Richmond, Virginia, United States | |
| United States, Washington | |
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| Seattle, Washington, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Mark A. Smith, MD, PhD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | Mark A. Smith, MD PhD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00807937 History of Changes |
| Other Study ID Numbers: | D1140C00014 |
| Study First Received: | December 12, 2008 |
| Results First Received: | July 29, 2010 |
| Last Updated: | September 16, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Generalized Anxiety Disorder GAD Anxiety |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Lorazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents |
Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013