NCT00306540

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

2.8 years

First QC Date

March 22, 2006

Last Update Submit

December 8, 2010

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Clinical Administered PTSD Scale (CAPS2)

Secondary Outcomes (4)

  • Hamilton Depression Scale (HAM-D)

  • Hamilton Anxiety Scale (HAM-A)

  • Posttraumatic Stress Disorder Checklist (PCL)

  • Clinical Global Impressions (CGI)

Study Arms (2)

1

ACTIVE COMPARATOR

Placebo Seroquel + existing therapy

Drug: quetiapine fumarate placebo

2

EXPERIMENTAL

Seroquel + existing therapy

Drug: Quetiapine Fumarate

Interventions

Quetiapine FumarateDRUG

oral flexible dose

Also known as: Seroquel
2
quetiapine fumarate placeboDRUG

oral 0 mg

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Brisbane, Queensland, Australia

Location

Research Site

Adelaide, South Australia, Australia

Location

Research Site

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Australia Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 24, 2006

Study Start

December 1, 2004

Primary Completion

September 1, 2007

Study Completion

August 1, 2008

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations

AU(3)