A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 725
- Locations
- 1
- Primary Endpoint
- Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A-AZD7325 2mg
AZD7325 2mg BID
Intervention: AZD7325 (Drug)
B-AZD7325 5mg
AZD7325 5mg BID
Intervention: AZD7325 (Drug)
C-AZD7325 10mg
AZD7325 10mg QD
Intervention: AZD7325 (Drug)
D-Placebo
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
- Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score(From randomization (baseline) to week 4)
- Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score(From baseline (randomization) to week 4)
- Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score(From baseline ( randomization) to week 4)
- Change in Sheehan Disability Scale (SDS) Global Total Score(From baseline ( randomization) to week 4)