Trial Outcomes & Findings for Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753) (NCT NCT02560389)

Last Updated: 2019-06-25

Results Overview

Differential galvanic skin response will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential galvanic skin response between the placebo, 100 mg, and 200 mg L-DOPA groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

Within 30 days of the MRI

Results posted on

2019-06-25

Participant Flow

103 participants enrolled but only 91 started in the study. 12 participants did not start in the study (6 did not show up, 3 were claustrophobic, 1 was too large to fit in MRI scanner and 2 were tested positive for having used cannabis)

Participant milestones

Participant milestones
Measure	Placebo Placebo administered in pill form once by mouth Placebo: Sugar pill packaged to resemble levodopa	100mg L-DOPA 100mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	200mg L-DOPA 200mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Overall Study STARTED	34	28	29
Overall Study COMPLETED	33	25	27
Overall Study NOT COMPLETED	1	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo administered in pill form once by mouth Placebo: Sugar pill packaged to resemble levodopa	100mg L-DOPA 100mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	200mg L-DOPA 200mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Overall Study Lost to Follow-up	1	2	2
Overall Study Tested positive for illicit substance	0	1	0

Baseline Characteristics

Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=33 Participants Placebo administered in pill form once by mouth Placebo: Sugar pill packaged to resemble levodopa	100mg L-DOPA n=25 Participants 100mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	200mg L-DOPA n=27 Participants 200mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	Total n=85 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 9 • n=5 Participants	35.1 years STANDARD_DEVIATION 9.7 • n=7 Participants	33.9 years STANDARD_DEVIATION 8.4 • n=5 Participants	34.23 years STANDARD_DEVIATION 9.03 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	25 Participants n=7 Participants	27 Participants n=5 Participants	85 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	33 participants n=5 Participants	25 participants n=7 Participants	27 participants n=5 Participants	85 participants n=4 Participants

PRIMARY outcome

Timeframe: Within 30 days of the MRI

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Placebo administered in pill form once by mouth Placebo: Sugar pill packaged to resemble levodopa	100mg L-DOPA n=25 Participants 100mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	200mg L-DOPA n=27 Participants 200mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Galvanic Skin Response	.37 Unitless Standard Deviation 0.05	.29 Unitless Standard Deviation 0.06	.36 Unitless Standard Deviation 0.05

SECONDARY outcome

Timeframe: Within 30 days of the MRI

Population: fMRI data was excluded for following number of participants due to artifacts caused by excessive head motion during the scan. Placebo n=4 participants, 100mg L-DOPA n=3 participants, 200mg L-DOPA n=3 participants

Amygdala is the part of the brain which controls emotions, survival instincts, and memory. PTSD patients exhibit hyperactivity in the amygdala in response to stimuli. Differential functional activation of the amygdala will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential functional activation between the placebo, 100 mg, and 200 mg L-DOPA groups.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Placebo administered in pill form once by mouth Placebo: Sugar pill packaged to resemble levodopa	100mg L-DOPA n=22 Participants 100mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	200mg L-DOPA n=24 Participants 200mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Percentage Change in Functional Activation of Amygdala	-0.1 Percentage change Standard Deviation 0.05	-0.06 Percentage change Standard Deviation 0.04	-0.05 Percentage change Standard Deviation 0.04

SECONDARY outcome

Timeframe: Within 30 days of the MRI

Population: Data was excluded for following number of participants due to artifacts caused by excessive head motion during the scan. Placebo n=4 participants, 100mg L-DOPA n=3 participants, 200mg L-DOPA n=3 participants

Differential functional activation of the anterior cingulate cortex will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential functional activation between the placebo, 100 mg, and 200 mg L-DOPA groups.

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Placebo administered in pill form once by mouth Placebo: Sugar pill packaged to resemble levodopa	100mg L-DOPA n=22 Participants 100mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.	200mg L-DOPA n=24 Participants 200mg levodopa administered in pill form once by mouth Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Functional Activation of Anterior Cingulate Cortex	0.08 percentage change Standard Error 0.07	0.09 percentage change Standard Error 0.04	0.07 percentage change Standard Error 0.05

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

100mg L-DOPA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

200mg L-DOPA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Josh Cisler

University of Wisconsin School of Medicine and Public Health, University of Wisconsin, Madison

Phone: 608-263-6100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place