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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Anxiety Disorders

Treatments: Drug: Lorazepam; Drug: Placebo; Drug: AZD7325

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807937

D1140C00014

Details and patient eligibility

About

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.

Enrollment: 369 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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369 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

AZD7325 5mg twice daily

Treatment:

Drug: AZD7325

Drug: AZD7325

B

Experimental group

Description:

AZD7325 15mg twice daily

Treatment:

Drug: AZD7325

Drug: AZD7325

C

Active Comparator group

Description:

Lorazepam 2mg twice daily

Treatment:

Drug: Lorazepam

D

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo