Trial Outcomes & Findings for An Open Trial of Cysteamine Treatment in Schizophrenia (NCT NCT01139125)
NCT ID: NCT01139125
Last Updated: 2014-11-20
Results Overview
We are measuring if this medication is appropriate for use in schizophrenia patients.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
4 months
Results posted on
2014-11-20
Participant Flow
Participant milestones
| Measure |
Cystagon (Cysteamine Bitartrate)
Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cystagon (Cysteamine Bitartrate)
Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
An Open Trial of Cysteamine Treatment in Schizophrenia
Baseline characteristics by cohort
| Measure |
Cystagon
n=3 Participants
One black male and two white males started the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 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
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsWe are measuring if this medication is appropriate for use in schizophrenia patients.
Outcome measures
Outcome data not reported
Adverse Events
Cystagon
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 |
Cystagon
n=3 participants at risk
Subjects taking 14 capsules per day for 16 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Jaw Hair Folliculitis
|
33.3%
1/3 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place