NCT00237393

Brief Summary

The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4

Geographic Reach
1 country

2 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

August 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 21, 2008

Status Verified

October 1, 2005

First QC Date

October 11, 2005

Last Update Submit

February 20, 2008

Conditions

PTSD

Keywords

PTSDPosttraumatic stress disorderTreatmentQuetiapine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (13)

  • 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)

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Quetiapine

Drug: Quetiapine

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

QuetiapineDRUG

Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.

1
PlaceboDRUG

Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.

2

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NM VA Healthcare System

Albuquerque, New Mexico, 87108, United States

Location

Ralph H. Johnson VAMC

Charleston, South Carolina, 29401, United States

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

  • Mark B Hamner, MD

    Ralph H. Johnson VAMC/Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 12, 2005

Study Start

August 1, 2003

Study Completion

December 1, 2007

Last Updated

February 21, 2008

Record last verified: 2005-10

Locations

US(2)