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Completed

NCT Number: NCT00807937

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

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.

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Key information

Conditions

Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD7325

Drug

4 tablets and 1 capsule taken twice a day for 28 days

Lorazepam

Drug

4 tablets and 1 capsule taken twice a day for 28 days

Placebo

Drug

4 tablets and 1 capsule taken twice a day for 28 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2008
Registry last updated
Oct 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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