Trial · Interventional

CompletedPhase 2Results postedRegistry data

Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)

Short name HELP

NCTNCT01188694Other id37340Other idR34MH087375Other id107654

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 42 participants (actual)
Sponsor: University of Washington · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Sept 2009
Primary completion: Apr 2013
Completion: Apr 2013
First posted: 25 Aug 2010 (estimated)
Last update posted: 14 Jun 2017
Conditions: Chronic Posttraumatic Stress Disorder

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011201220132014

Ph 2
HELP
NCT01188694
Sept 2009 to Apr 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Psychotherapy plus Methylene Blue, USPDrug
Psychotherapy plus PlaceboBehavioral
Delayed PsychotherapyBehavioral

Arms3

Experimental
Psychotherapy plus Methylene Blue, USP
Placebo comparator
Psychotherapy Plus Placebo
Other
Delayed Psychotherapy

Primary outcomes1

Outcomes the sponsor listed as primary.

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-)
Registry description
PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)

PTSD Symptom Severity-Interview (PSS-I)

Group	Value (units on a scale)	Spread
Psychotherapy Plus Methylene Blue, USP	32.07	6.17
Psychotherapy Plus Placebo	31.38	6.88
Delayed Psychotherapy	32.73	7.24

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Psychotherapy Plus Methylene Blue, USPPsychotherapy 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.	–	0 / 15	4 / 15
Psychotherapy Plus PlaceboPsychotherapy 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.	–	0 / 16	4 / 16
Delayed PsychotherapyDelayed 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).	–	0 / 11	1 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedZoellner 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 28686823

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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