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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.

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

Research Site

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)

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.

Age, Customized

Gender, Male/Female

Change from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score

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.

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

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.

Change in psychic anxiety symptoms as measured by HAM-A psychic anxiety factor score

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

Change in somatic symptoms as measured by HAM-A somatic factor score

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)

Change in Sheehan Disability Scale (SDS) global total score

Overall Study

Screening for eligibility and wash-out of restriced medications.
725 subjects enrolled but 424 subjects were randomized. 
Number of participants analyzed is the number of subjects in MITT (modified intent to treat) population, it is different with any of population listed in the participant flow chart.

Arms	Assigned Interventions
Experimental: A-AZD7325 2mg AZD7325 2mg BID	Drug: AZD7325 2 tablets taken twice a day for 28 days
Experimental: B-AZD7325 5mg AZD7325 5mg BID	Drug: AZD7325 2 tablets taken twice a day for 28 days
Experimental: C-AZD7325 10mg AZD7325 10mg QD	Drug: AZD7325 2 tablets taken twice a day for 28 days
Experimental: D-Placebo Placebo	Drug: Placebo 2 tablets taken twice a day for 28 days

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

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=250&filename=CSR-D1140C00006.pdf

CSR-D1140C00006.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator