Quetiapine Augmentation for Treatment-resistant PTSD

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00292370
First received: February 13, 2006
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.


Condition Intervention Phase
Combat Disorders
Stress Disorders, Post-Traumatic
Drug: Phases I & II
Drug: Phase II
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Total CAPS change score . [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS [ Time Frame: Baseline to endpoint change scores ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Open-Label Paroxetine
Drug: Phases I & II
Open-label Paroxetine
Placebo Comparator: Arm 2
Double-blind quetiapine or placebo
Drug: Phases I & II
Open-label Paroxetine
Drug: Phase II
Double-blind quetiapine or placebo

Detailed Description:

This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.

In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran age 18 to 75.
  • Competent to give informed consent.
  • Meeting DSM-IV criteria for PTSD.
  • Minimal CAPS score of 50 at baseline.
  • If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.
  • Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine [5 weeks])

    • monoamine oxidase inhibitors (MAOIs [4 weeks])
    • depot neuroleptics [4 weeks])
    • or any investigational drug within 30 days prior to study enrollment.
  • To be eligible for Phase II

    • patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8
    • must have PTSD symptoms at least moderate severity on CGI-S
    • and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.

Exclusion Criteria:

  • History of sensitivity to paroxetine or quetiapine.
  • Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).
  • Women who are

    • breast-feeding
    • pregnant
    • expect to become pregnant during the course of the study
    • or are sexually active and are not using a medically acceptable method of birth control.
  • Presence of clinically significant hepatic

    • cardiovascular
    • or other medical conditions that may prevent safe administration of paroxetine or quetiapine
    • or any other clinically significant unstable medical conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292370

Locations
United States, South Carolina
Ralph H. Johnson
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mark Benjamin Hamner, MD BS Ralph H. Johnson VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00292370     History of Changes
Other Study ID Numbers: CLIN-006-04F
Study First Received: February 13, 2006
Last Updated: August 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Atypical Antipsychotics
Controlled Trial
Paroxetine
Quetiapine
Stress Disorders, Post-Traumatic
Treatment refractory
Treatment resistant

Additional relevant MeSH terms:
Combat Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Paroxetine
Quetiapine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014