Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
HELP
3 other identifiers
interventional
42
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2009
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
March 1, 2017
3.6 years
July 20, 2010
January 6, 2017
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
PTSD Symptom Severity-Interview (PSS-I)
PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)
Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)
Study Arms (3)
Psychotherapy plus Methylene Blue, USP
EXPERIMENTALPsychotherapy Plus Placebo
PLACEBO COMPARATORDelayed Psychotherapy
OTHERInterventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
- Between the age of 18 and 65.
You may not qualify if:
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
- 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).
- Current diagnosis of alcohol or substance dependence within the 3 previous months.
- Unwilling or unable to discontinue current trauma-focused psychotherapy or psychotropic medication (at least 1 month medication free).
- Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
- Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or hematological disorder or current seizure disorder.
- 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.
- A history of hypersensitivity or allergy to MB.
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- Glucose-6-phosphate dehydrogenase deficiency.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- University of Texascollaborator
- University of Pennsylvaniacollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (3)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas
Austin, Texas, 78712, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Zoellner LA, Telch M, Foa EB, Farach FJ, McLean CP, Gallop R, Bluett EJ, Cobb A, Gonzalez-Lima F. Enhancing Extinction Learning in Posttraumatic Stress Disorder With Brief Daily Imaginal Exposure and Methylene Blue: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e782-e789. doi: 10.4088/JCP.16m10936.
PMID: 28686823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lori Zoellner
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Lori A Zoellner, PhD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Psychology
Study Record Dates
First Submitted
July 20, 2010
First Posted
August 25, 2010
Study Start
September 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-03