Trial Outcomes & Findings for A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD (NCT NCT02934932)

NCT ID: NCT02934932

Last Updated: 2019-03-05

Results Overview

Evaluate the effects of two doses of brexpiprazole on locus coeruleus (LC) norepinephrine (NE) neuron activity.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline to 6 weeks for each treatment arm
• Results posted on: 2019-03-05

Participant Flow

15 participants signed consent; 6 screen failed. All subjects received all three treatments with treatment order randomized within each subject.

Participant milestones

Measure	All Participants All participants who began the study.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD

Baseline characteristics by cohort

Measure	All Participants n=15 Participants All participants who signed consent.
Age, Continuous	44.4 years STANDARD_DEVIATION 12.49 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks for each treatment arm

Population: Data not collected.

Evaluate the effects of two doses of brexpiprazole on locus coeruleus (LC) norepinephrine (NE) neuron activity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 weeks for each treatment arm

Population: Data not collected.

Determine the effect of brexpiprazole therapy on PTSD symptom severity

Outcome measures

Outcome data not reported

Adverse Events

All Participants

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

Dr. Steven Szabo

Duke University

Phone: 919-681-8742

Email: steven.szabo@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place