Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

Summary

Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.

Conditions

• Chronic Posttraumatic Stress Disorder

Interventions

DRUG

Psychotherapy plus Methylene Blue, USP

This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.

BEHAVIORAL

Psychotherapy plus Placebo

This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.

BEHAVIORAL

Delayed Psychotherapy

Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).

Sponsors & Collaborators

• University of Texas

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Lori A Zoellner, PhD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• United States

Study Locations