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Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00807937
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : October 8, 2010
Last Update Posted : October 8, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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
Anxiety Disorders Drug: AZD7325 Drug: Lorazepam Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Lorazepam

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: 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 :
  1. Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score [ Time Frame: 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

  2. Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score [ Time Frame: 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


  3. Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score [ Time Frame: 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.

  4. 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 ]

    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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807937


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Mark A. Smith, MD, PhD AstraZeneca
More Information
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Responsible Party: Mark A. Smith, MD PhD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00807937    
Other Study ID Numbers: D1140C00014
First Posted: December 15, 2008    Key Record Dates
Results First Posted: October 8, 2010
Last Update Posted: October 8, 2010
Last Verified: September 2010
Keywords provided by AstraZeneca:
Generalized Anxiety Disorder
GAD
Anxiety
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action