Skip to main content
OpenTrials
Completed

NCT Number: NCT00808249

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

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.

Completed

Looking for future studies?

Notify Me

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, Birmingham, Alabama, United States

Loading trial locations.

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

2 tablets taken twice a day for 28 days

Placebo

Drug

2 tablets taken twice a day for 28 days

Primary outcomes

  1. Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

    Time frame: From randomization (baseline) to week 4

    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.

Secondary outcomes

  1. Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score

    Time frame: From randomization (baseline) to week 4

    The 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.

  2. Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score

    Time frame: From baseline (randomization) to week 4

    The 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.

  3. Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score

    Time frame: From baseline ( randomization) to week 4

    The 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

  4. Change in Sheehan Disability Scale (SDS) Global Total Score

    Time frame: From baseline ( randomization) to week 4

    The 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2008
Registry last updated
Jun 20, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.