Trial Outcomes & Findings for Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD) (NCT NCT01188694)
NCT ID: NCT01188694
Last Updated: 2017-06-14
Results Overview
PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Psychotherapy Plus Methylene Blue, USP
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.
|
Psychotherapy Plus Placebo
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
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
11
|
|
Overall Study
COMPLETED
|
10
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Psychotherapy Plus Methylene Blue, USP
n=15 Participants
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.
|
Psychotherapy Plus Placebo
n=16 Participants
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
n=11 Participants
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).
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
11 participants
n=5 Participants
|
42 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)Population: Intent to Treat
PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)
Outcome measures
| Measure |
Psychotherapy Plus Methylene Blue, USP
n=15 Participants
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.
|
Psychotherapy Plus Placebo
n=16 Participants
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
n=11 Participants
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).
|
|---|---|---|---|
|
PTSD Symptom Severity-Interview (PSS-I)
3 Month Follow-up
|
7.63 units on a scale
Standard Deviation 5.53
|
10.93 units on a scale
Standard Deviation 9.95
|
7.25 units on a scale
Standard Deviation 9.82
|
|
PTSD Symptom Severity-Interview (PSS-I)
Pre-Treatment
|
32.07 units on a scale
Standard Deviation 6.17
|
31.38 units on a scale
Standard Deviation 6.88
|
32.73 units on a scale
Standard Deviation 7.24
|
|
PTSD Symptom Severity-Interview (PSS-I)
Post-Treatment
|
17.10 units on a scale
Standard Deviation 10.57
|
14.67 units on a scale
Standard Deviation 9.27
|
29.60 units on a scale
Standard Deviation 8.40
|
|
PTSD Symptom Severity-Interview (PSS-I)
1 Month Follow-up
|
10.33 units on a scale
Standard Deviation 3.77
|
13.33 units on a scale
Standard Deviation 9.15
|
28.33 units on a scale
Standard Deviation 7.43
|
Adverse Events
Psychotherapy Plus Methylene Blue, USP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Psychotherapy Plus Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Delayed Psychotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psychotherapy Plus Methylene Blue, USP
n=15 participants at risk
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.
|
Psychotherapy Plus Placebo
n=16 participants at risk
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
n=11 participants at risk
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).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea or Gastrointestinal
|
26.7%
4/15
|
18.8%
3/16
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety or Depression
|
6.7%
1/15
|
6.2%
1/16
|
0.00%
0/11
|
|
Eye disorders
Eye Infection
|
0.00%
0/15
|
0.00%
0/16
|
9.1%
1/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place