Trial Outcomes & Findings for Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder (NCT NCT00805493)
NCT ID: NCT00805493
Last Updated: 2017-09-15
Results Overview
This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
8 week trial with the study running for about 4 years.
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
Riluzole
Those randomized to riluzole
|
Placebo
Those randomized to receive placebo
|
Not Randomized
Those who withdrew prior to the decision to randomize
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Riluzole
n=3 Participants
|
Placebo
n=2 Participants
|
Not Randomized
n=1 Participants
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
LTE18
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
BTWN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
GTE65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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)
Hawaiian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 week trial with the study running for about 4 years.This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.
Outcome measures
| Measure |
Riluzole
n=3 Participants
The group randomized to riluzole
|
Placebo
n=2 Participants
|
Not Randomized
Those who withdrew prior to the decision to randomize
|
|---|---|---|---|
|
Clinical Global Impression--Improvement
|
4 units on a scale
Standard Deviation .82
|
4 units on a scale
Standard Deviation 1
|
—
|
PRIMARY outcome
Timeframe: Weekly for 8 weeksA standard measure of severity of anxiety over the previous week. The score ranges from a total of 0-25, with 0 being absence of symptoms and impairment, and 25 being marked symptoms and severe impairment. The outcome measure for each participant is the change in PARS, that is, the difference at week 8 compared to baseline (when medication-free).
Outcome measures
| Measure |
Riluzole
n=2 Participants
The group randomized to riluzole
|
Placebo
|
Not Randomized
n=3 Participants
Those who withdrew prior to the decision to randomize
|
|---|---|---|---|
|
Pediatric Anxiety Scale
|
1.67 units on a scale
Standard Deviation 3.09
|
—
|
-2.5 units on a scale
Standard Deviation 0.5
|
Adverse Events
Riluzole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Riluzole
n=3 participants at risk
|
Placebo
n=2 participants at risk
|
Not Randomized
n=1 participants at risk
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
Additional Information
Kenneth Towbin, M.D., Chief Clinical Child and Adolescent Psychiatry
Emotion and Development Branch, NIMH-IRP
Phone: 301-402-4403
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place