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Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD) (PTSD)

Primary Purpose

PTSD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Placebo
Sponsored by
Ralph H. Johnson VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Posttraumatic stress disorder, Treatment, Quetiapine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD. Score of at least 50 on the CAPS-SX at baseline. Competent to give informed consent. If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential. Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase. Other medications, if any, must have been kept stable for at least one month prior to randomization. Exclusion Criteria: History of sensitivity to quetiapine Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period. Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease. Medical disorders that may cause or exacerbate anxiety symptoms. Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria. Schizophrenia, schizoaffective disorder, or bipolar disorder. Suicidal or homicidal ideation or other clinically significant dangerousness Currently seeking compensation or increase in compensation for the effects of the trauma. Initiation or change in psychotherapy within 3 months of randomization.

Sites / Locations

  • NM VA Healthcare System
  • Ralph H. Johnson VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Quetiapine

Outcomes

Primary Outcome Measures

Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12

Secondary Outcome Measures

Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
Hamilton Depression Rating Scale (HAMD)
Hamilton Rating Scale of Anxiety (HAMA)
Clinical Global Impression Severity Scale (CGI-S)
Clinical Global Impression Improvement Scale (CGI-I)
Davidson Trauma Scale (DTS)
Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
SDS
Arizona Sexual Experience Scale (ASEX)
AIMS
BAS
SAS

Full Information

First Posted
October 11, 2005
Last Updated
February 20, 2008
Sponsor
Ralph H. Johnson VA Medical Center
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00237393
Brief Title
Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)
Acronym
PTSD
Official Title
A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ralph H. Johnson VA Medical Center
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
Detailed Description
Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms. Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy. Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Posttraumatic stress disorder, Treatment, Quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Quetiapine
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
Primary Outcome Measure Information:
Title
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
Secondary Outcome Measure Information:
Title
Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
Title
Hamilton Depression Rating Scale (HAMD)
Title
Hamilton Rating Scale of Anxiety (HAMA)
Title
Clinical Global Impression Severity Scale (CGI-S)
Title
Clinical Global Impression Improvement Scale (CGI-I)
Title
Davidson Trauma Scale (DTS)
Title
Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
Title
SDS
Title
Arizona Sexual Experience Scale (ASEX)
Title
AIMS
Title
BAS
Title
SAS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD. Score of at least 50 on the CAPS-SX at baseline. Competent to give informed consent. If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential. Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase. Other medications, if any, must have been kept stable for at least one month prior to randomization. Exclusion Criteria: History of sensitivity to quetiapine Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period. Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease. Medical disorders that may cause or exacerbate anxiety symptoms. Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria. Schizophrenia, schizoaffective disorder, or bipolar disorder. Suicidal or homicidal ideation or other clinically significant dangerousness Currently seeking compensation or increase in compensation for the effects of the trauma. Initiation or change in psychotherapy within 3 months of randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark B Hamner, MD
Organizational Affiliation
Ralph H. Johnson VAMC/Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
NM VA Healthcare System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Ralph H. Johnson VAMC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

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Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

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