Quetiapine Augmentation for Treatment-resistant PTSD

NCT ID: NCT00292370

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-05-31

Brief Summary

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.

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.

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1: Open Label (OL) Paroxetine

Open-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.

Group Type: OTHER

Open Label (OL) Paroxetine

Intervention Type: DRUG

Open-label Paroxetine

Arm 2 OL Paroxetine + DB Placebo

In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.

Group Type: PLACEBO_COMPARATOR

Open Label (OL) Paroxetine

Intervention Type: DRUG

Open-label Paroxetine

Placebo

Intervention Type: DRUG

Double-blind placebo taken with OL paroxetine

Arm 3: OL Paroxetine + DB Quetiapine

In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.

Group Type: EXPERIMENTAL

Open Label (OL) Paroxetine

Intervention Type: DRUG

Open-label Paroxetine

Quetiapine

Intervention Type: DRUG

Double-blind quetiapine taken with OL paroxetine

Interventions

Open Label (OL) Paroxetine

Open-label Paroxetine

Intervention Type: DRUG

Placebo

Double-blind placebo taken with OL paroxetine

Intervention Type: DRUG

Quetiapine

Double-blind quetiapine taken with OL paroxetine

Intervention Type: DRUG

Other Intervention Names

Paxil; sugar pill; Seroquel

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark B Hamner, MD BS

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center

Locations

Birmingham VA Medical Center

Birmingham, Alabama, United States

Tuscaloosa VAMC

Tuscaloosa, Alabama, United States

Ralph H. Johnson

Charleston, South Carolina, United States

Countries

United States

References

Weathers FW, Keane TM, Davidson JR. Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety. 2001;13(3):132-56. doi: 10.1002/da.1029.

Reference Type: BACKGROUND

PMID: 11387733 (View on PubMed)

Related Links

https://www.ptsd.va.gov/index.asp

The National Center for PTSD is part of the US Department of Veterans Affairs

Other Identifiers

CLIN-006-04F

Identifier Type: -

Identifier Source: org_study_id