Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
Condition: Chronic Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Psychotherapy plus Methylene Blue, USP; Psychotherapy plus Placebo; Delayed Psychotherapy
Intervention description: 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).
Intervention MeSH terms: Methylene Blue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.