Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00306540

Enrollment

Registered

2006-03-24

Start date

2004-12-31

Completion date

2008-08-31

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

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.

Interventions

DRUGQuetiapine Fumarate

oral flexible dose

DRUGquetiapine fumarate placebo

oral 0 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Clinical Administered PTSD Scale (CAPS2)	—

Secondary

Measure	Time frame
Hamilton Depression Scale (HAM-D)	—
Hamilton Anxiety Scale (HAM-A)	—
Posttraumatic Stress Disorder Checklist (PCL)	—
Clinical Global Impressions (CGI)	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026