Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2009
End Date:April 2013

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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.


The psychotherapy the investigators are offering in this study is a type of cognitive
behavioral therapy called imaginal exposure. In imaginal exposure, the investigators
encourage the client to approach the memory of the trauma by recounting the trauma story to
the therapist and discussing his or her reactions to the memory.

Inclusion Criteria:

1. Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of
12 weeks since the traumatic event.

2. Between the age of 18 and 65.

Exclusion Criteria:

1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder
as defined by the DSM-IV.

2. Current diagnosis of bipolar disorder, depression with psychotic features, or
depression severe enough to require immediate psychiatric treatment (i.e., serious
suicide risk with intent and plan).

3. Current diagnosis of alcohol or substance dependence within the 3 previous months.

4. Unwilling or unable to discontinue current trauma-focused psychotherapy or
psychotropic medication (at least 1 month medication free).

5. Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).

6. Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic,
retinal, gastrointestinal, or hematological disorder or current seizure disorder.

7. Pregnant or nursing females; females of childbearing potential who are unwilling or
unable to use an acceptable method of contraception for the duration of active
treatment.

8. A history of hypersensitivity or allergy to MB.

9. Any condition possibly affecting drug absorption (e.g., gastrectomy).

10. Glucose-6-phosphate dehydrogenase deficiency.

11. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that, in the judgment of the Medical Directors, would make the
participant inappropriate for entry.
We found this trial at
3
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San Antonio, Texas 78229
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Seattle, Washington 98195
(206) 543-2100
University of Washington Founded in 1861 by a private gift of 10 acres in what...
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