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

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807937

Enrollment

369

Registered

2008-12-15

Start date

2008-12-31

Completion date

2009-05-31

Last updated

2010-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Generalized Anxiety Disorder, GAD, Anxiety

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.

Interventions

DRUGAZD7325

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

DRUGLorazepam

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Baseline to week 4	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

Secondary

Measure	Time frame	Description
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	Baseline to week 4	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
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score	Baseline to week 4	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
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score	Baseline to week 4	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.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score	Baseline to week 4	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

Countries

United States

Participant flow

Recruitment details

International multi-center study, 43 sites recruited between Dec 2008 and May 2009

Pre-assignment details

Screening for eligibility and wash-out of restriced medications

Participants by arm

Arm	Count
AZD7325 5 mg AZD7325 5 mg twice daily (BID)	93
AZD7325 15 mg AZD7325 15 mg twice daily (BID)	92
Lorazepam Lorazepam 2 mg twice daily (BID)	92
Placebo Placebo	92
Total	369

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	12	12	5	4
Overall Study	All other reasons (not provided)	2	4	0	1
Overall Study	Intake of prohibited medicine	0	0	2	0
Overall Study	Lack of Efficacy	0	0	1	2
Overall Study	Lost to Follow-up	4	0	2	1
Overall Study	Protocol Violation	4	5	3	3
Overall Study	Withdrawal by Subject	5	4	1	4

Baseline characteristics

Characteristic	AZD7325 5 mg	AZD7325 15 mg	Lorazepam	Placebo	Total
Age, Customized 18-39 years	46 Participants	42 Participants	43 Participants	44 Participants	175 Participants
Age, Customized 40-65 years	47 Participants	50 Participants	49 Participants	48 Participants	194 Participants
Sex: Female, Male Female	58 Participants	43 Participants	45 Participants	45 Participants	191 Participants
Sex: Female, Male Male	35 Participants	49 Participants	47 Participants	47 Participants	178 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	63 / 93	59 / 92	65 / 92	51 / 92
serious Total, serious adverse events	0 / 93	0 / 92	0 / 92	0 / 92

Outcome results

Primary

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