Back to resultsUse of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Quetiapine Fumarate
quetiapine fumarate placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder
Eligibility Criteria
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 Exclusion Criteria: History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo Seroquel + existing therapy
Seroquel + existing therapy
Outcomes
Primary Outcome Measures
Clinical Administered PTSD Scale (CAPS2)
Secondary Outcome Measures
Hamilton Depression Scale (HAM-D)
Hamilton Anxiety Scale (HAM-A)
Posttraumatic Stress Disorder Checklist (PCL)
Clinical Global Impressions (CGI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00306540
Brief Title
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Placebo Seroquel + existing therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Seroquel + existing therapy
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Other Intervention Name(s)
Seroquel
Intervention Description
oral flexible dose
Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate placebo
Intervention Description
oral 0 mg
Primary Outcome Measure Information:
Title
Clinical Administered PTSD Scale (CAPS2)
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Title
Hamilton Anxiety Scale (HAM-A)
Title
Posttraumatic Stress Disorder Checklist (PCL)
Title
Clinical Global Impressions (CGI)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Australia Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
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