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

Phase 2

Completed

• Conditions: Anxiety Disorders
• Interventions: Drug: AZD7325; Drug: Placebo

• Registration Number: NCT00808249
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-01-28
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-20
• Results First Posted: 2011-05-19
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 725

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-AZD7325 2mg	AZD7325	AZD7325 2mg BID
D-Placebo	Placebo	Placebo
B-AZD7325 5mg	AZD7325	AZD7325 5mg BID
C-AZD7325 10mg	AZD7325	AZD7325 10mg QD

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	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 Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	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.
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score	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.
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score	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
Change in Sheehan Disability Scale (SDS) Global Total Score	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)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Middleton, Wisconsin, United States