NCT00807937 - Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325 | Crick | Crick

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

Phase 2CompletedNCT00807937

AstraZeneca369 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

369

Conditions

Anxiety Disorders

Interventions

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

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (51)

Outcomes

Primary Outcomes

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

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

Time frame: Baseline to week 4

Secondary Outcomes

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

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

Time frame: Baseline to week 4

Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score

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

Time frame: Baseline to week 4

Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score

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.

Time frame: Baseline to week 4

Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score

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

Time frame: Baseline to week 4

Data from ClinicalTrials.gov

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