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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02934932
Recruitment Status : Terminated (Terminated due to slow enrollment.)
First Posted : October 17, 2016
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Post Traumatic Stress Disorder
Intervention Drug: Brexpiprazole
Enrollment 15
Recruitment Details  
Pre-assignment Details 15 participants signed consent; 6 screen failed. All subjects received all three treatments with treatment order randomized within each subject.
Arm/Group Title All Participants
Hide Arm/Group Description All participants who began the study.
Period Title: Overall Study
Started 9
Completed 6
Not Completed 3
Arm/Group Title All Participants
Hide Arm/Group Description All participants who signed consent.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Six participants screen failed. All other subjects received all three treatments with treatment order randomized within each subject.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
44.4  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  20.0%
White
11
  73.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Change in Resting Pupil Diameter
Hide Description Evaluate the effects of two doses of brexpiprazole on locus coeruleus (LC) norepinephrine (NE) neuron activity.
Time Frame Baseline to 6 weeks for each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Brexpiprazole 2mg Brexpiprazole 4mg Placebo
Hide Arm/Group Description:

Subjects will be titrated to this dose of brexpiprazole for 6 weeks.

Brexpiprazole: Comparison of brexpiprazole to placebo

Subjects will be titrated to this dose of brexpiprazole for 6 weeks.

Brexpiprazole: Comparison of brexpiprazole to placebo

Subjects will be titrated to this dose of placebo for 6 weeks.

Brexpiprazole: Comparison of brexpiprazole to placebo

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in CAPS-5 Ratings Score
Hide Description Determine the effect of brexpiprazole therapy on PTSD symptom severity
Time Frame Baseline to 6 weeks for each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Brexpiprazole 2mg Brexpiprazole 4mg Placebo
Hide Arm/Group Description:

Subjects will be titrated to this dose of brexpiprazole for 6 weeks.

Brexpiprazole: Comparison of brexpiprazole to placebo

Subjects will be titrated to this dose of brexpiprazole for 6 weeks.

Brexpiprazole: Comparison of brexpiprazole to placebo

Subjects will be titrated to this dose of placebo for 6 weeks.

Brexpiprazole: Comparison of brexpiprazole to placebo

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description All participants who began the study.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Steven Szabo
Organization: Duke University
Phone: 919-681-8742
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02934932     History of Changes
Other Study ID Numbers: Pro00071923
First Submitted: October 14, 2016
First Posted: October 17, 2016
Results First Submitted: January 2, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019