Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

Chronic Posttraumatic Stress Disorder Clinical Trial

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Official title:

Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188694
• Other study ID #: 37340-K
• Secondary ID: R34MH08737510765
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2010
• Last updated: April 25, 2016
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of Texas	Austin	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), University of Pennsylvania, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptom severity	PTSD Symptom Scale - Interview Version	Pre- and post-treatment, 1-month and 3-month follow-ups	No
Secondary	Depression symptom severity	Quick Inventory of Depressive Symptomatology - Self-Report	Pre- and post-treatment, 1-month and 3-month follow-ups	No
Secondary	Trauma-related cognitions	Post-Traumatic Cognitions Inventory - Self-Report	Pre- and post-treatment, 1-month and 3-month follow-ups	No
Secondary	General physical and psychological health	Medical Outcomes Study Short Form 36, Version 2 - Self-report	Pre- and post-treatment, 1-month and 3-month follow-ups	No
Secondary	Functioning in work, social/leisure activities, and family/home life	Sheehan Disability Scale - Self-report	Pre- and post-treatment, 1-month and 3-month follow-ups	No