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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00306540




Registration number
NCT00306540
Ethics application status
Date submitted
22/03/2006
Date registered
24/03/2006
Date last updated
9/12/2010

Titles & IDs
Public title
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Scientific title
A Multicentre, Parallel Group, Randomised, Double Blind, Placebo Controlled Study of the Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Secondary ID [1] 0 0
D1449L00005
Secondary ID [2] 0 0
AU-SEA-0006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine Fumarate
Treatment: Drugs - quetiapine fumarate placebo

Active Comparator: 1 - Placebo Seroquel + existing therapy

Experimental: 2 - Seroquel + existing therapy


Treatment: Drugs: Quetiapine Fumarate
oral flexible dose

Treatment: Drugs: quetiapine fumarate placebo
oral 0 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Administered PTSD Scale (CAPS2)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Hamilton Depression Scale (HAM-D)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Hamilton Anxiety Scale (HAM-A)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Posttraumatic Stress Disorder Checklist (PCL)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Clinical Global Impressions (CGI)
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms
of PTSD for a minimum of 12 months prior to giving consent to the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of psychotic condition / quetiapine or other anti-psychotics not worked
previously / Taking prohibited medications (mood stabilizers / substance abuse)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Brisbane
Recruitment hospital [2] 0 0
Research Site - Adelaide
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate how effective quetiapine versus placebo is when
added to an existing therapy, in reducing the symptoms of PTSD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00306540
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Australia Medical Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00306540