Trial Outcomes & Findings for 18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder (NCT NCT03902613)
NCT ID: NCT03902613
Last Updated: 2023-11-13
Results Overview
Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
15 minutes
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Lurasidone
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Lurasidone
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Lurasidone
n=1 Participants
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
|
|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutesMeasures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome.
Outcome measures
| Measure |
Lurasidone
n=1 Participants
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
|
|---|---|
|
Montgomery Asberg Depression Rating Scale
|
34 units on a scale
Interval 34.0 to 34.0
|
Adverse Events
Lurasidone
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. Martin Lan
Columbia University Irving Medical Center
Phone: 646 774 7610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place