Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety.

It had three arms (groups): Psychotherapy plus Methylene Blue, USP (experimental), Psychotherapy Plus Placebo (placebo comparator) and Delayed Psychotherapy (other).

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-09 with completion listed for 2013-04.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PTSD Symptom Severity-Interview (PSS-I) (time frame: Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 42 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.