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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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

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

Research Site

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)

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

Age, Customized

Gender, Male/Female

Change in the Hamilton Rating Scale for Anxiety (HAM-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

Change in Hospital Anxiety and Depression Scale for anxiety (HADS-A) total 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

Change in psychic anxiety factor as measured by HAM-A psychic 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.

Change in somatic symptoms as measured by HAM-A somatic cluster 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

Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) percent maximum total score

Overall Study

Screening for eligibility and wash-out of restriced medications

Arms	Assigned Interventions
Experimental: A AZD7325 5mg twice daily	Drug: AZD7325 4 tablets and 1 capsule taken twice a day for 28 days
Experimental: B AZD7325 15mg twice daily	Drug: AZD7325 4 tablets and 1 capsule taken twice a day for 28 days
Active Comparator: C Lorazepam 2mg twice daily	Drug: Lorazepam 4 tablets and 1 capsule taken twice a day for 28 days
Placebo Comparator: D Placebo	Drug: Placebo 4 tablets and 1 capsule taken twice a day for 28 days

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=251&filename=CSR-D1140C00014.pdf

CSR-D1140C00014.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator