Trial · NCT00808249

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

NCT00808249, Phase 2, Completed, AstraZeneca; results first posted 2011-05-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD). Trials, record NCT00808249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00808249

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
NCT number: NCT00808249
Status: Completed
Phases: Phase 2
Enrollment: 725 participants, actual
Lead sponsor: AstraZeneca
Conditions: Anxiety Disorders
Interventions: AZD7325, AZD7325, AZD7325, Placebo
First posted: 2008-12-15
Last updated: 2011-06-20
Results first posted: 2011-05-19

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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)

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	From randomization (baseline) to week 4	Units on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	From randomization (baseline) to week 4	Units on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score	From baseline (randomization) to week 4	Unit on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score	From baseline ( randomization) to week 4	Units on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Sheehan Disability Scale (SDS) Global Total Score	From baseline ( randomization) to week 4	Units on scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	A-AZD7325 2 mg	-10.9	Standard Error 0.87	Units on scale
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	B-AZD7325 5 mg	-11.1	Standard Error 0.86	Units on scale
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	C-AZD7325 10 mg	-11.5	Standard Error 0.87	Units on scale
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	D-Placebo	-10.9	Standard Error 0.88	Units on scale
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	A-AZD7325 2 mg	-4.5	Standard Error 0.49	Units on scale
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	B-AZD7325 5 mg	-4.2	Standard Error 0.49	Units on scale
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	C-AZD7325 10 mg	-5.2	Standard Error 0.50	Units on scale
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	D-Placebo	-4.6	Standard Error 0.50	Units on scale
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score	A-AZD7325 2 mg	-5.9	Standard Error 0.51	Unit on scale
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score	B-AZD7325 5 mg	-5.8	Standard Error 0.51	Unit on scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	A-AZD7325 2 mg	107
Overall Study	STARTED	B-AZD7325 5 mg	106
Overall Study	STARTED	C-AZD7325 10 mg	105
Overall Study	STARTED	D-Placebo	106
Overall Study	COMPLETED	A-AZD7325 2 mg	90
Overall Study	COMPLETED	B-AZD7325 5 mg	91
Overall Study	COMPLETED	C-AZD7325 10 mg	83
Overall Study	COMPLETED	D-Placebo	90
Overall Study	NOT COMPLETED	A-AZD7325 2 mg	17
Overall Study	NOT COMPLETED	B-AZD7325 5 mg	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dizziness	Nervous system disorders	A-AZD7325 2 mg	13	106
other	Dizziness	Nervous system disorders	B-AZD7325 5 mg	18	106
other	Dizziness	Nervous system disorders	C-AZD7325 10 mg	32	105
other	Dizziness	Nervous system disorders	D-Placebo	12	105
other	Headache	Nervous system disorders	A-AZD7325 2 mg	8	106
other	Headache	Nervous system disorders	B-AZD7325 5 mg	17	106
other	Headache	Nervous system disorders	C-AZD7325 10 mg	9	105
other	Headache	Nervous system disorders	D-Placebo	14	105
other	Sedation	Nervous system disorders	A-AZD7325 2 mg	5	106
other	Sedation	Nervous system disorders	B-AZD7325 5 mg	6	106

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	A-AZD7325 2 mg
Total, all-cause mortality	B-AZD7325 5 mg
Total, all-cause mortality	C-AZD7325 10 mg
Total, all-cause mortality	D-Placebo
Total, other adverse events	A-AZD7325 2 mg	13
Total, other adverse events	B-AZD7325 5 mg	18
Total, other adverse events	C-AZD7325 10 mg	32
Total, other adverse events	D-Placebo	14
Total, serious adverse events	A-AZD7325 2 mg	1
Total, serious adverse events	B-AZD7325 5 mg	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00808249

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API reference For AI assistants