Trial Outcomes & Findings for Riluzole in the Treatment of Bipolar Depression (NCT NCT00544544)
NCT ID: NCT00544544
Last Updated: 2018-08-07
Results Overview
The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.
COMPLETED
NA
14 participants
Baseline (week 0) - week 6
2018-08-07
Participant Flow
Participant milestones
| Measure |
Riluzole
Riluzole 100-200 mg/day
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Riluzole
Riluzole 100-200 mg/day
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Riluzole in the Treatment of Bipolar Depression
Baseline characteristics by cohort
| Measure |
Riluzole
n=14 Participants
Riluzole 100-200 mg/day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) - week 6The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.
Outcome measures
| Measure |
Riluzole
n=14 Participants
Riluzole 100-200 mg/day
|
|---|---|
|
Change in Hamilton Depression Rating Scale
|
-12.6 units on a scale
Interval -16.5 to -8.6
|
SECONDARY outcome
Timeframe: Baseline (week 0) - week 6The Montgomery-Asberg Depression Rating Scale is a clinician-rated scale that measures the severity of depression symptoms. The 10 items measured are apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Minimum score is zero and maximum score is 60. Higher scores represent more severe depressive symptoms.
Outcome measures
| Measure |
Riluzole
n=14 Participants
Riluzole 100-200 mg/day
|
|---|---|
|
Montgomery Asberg Depression Rating Scale
|
-13.0 units on a scale
Interval -18.0 to -8.0
|
SECONDARY outcome
Timeframe: Baseline (week 0) - week 6The Young Mania Rating Scale is a clinician-rated scale that measures the severity of mania symptoms. The 11 items measures are elevated mood, increased motor activity, sexual interest, sleep, irritability, speech, language-thought disorder, thought content, aggressive behavior, appearance, and insight. Minimum score is zero and maximum score is 60. Higher scores represent more severe mania symptoms.
Outcome measures
| Measure |
Riluzole
n=14 Participants
Riluzole 100-200 mg/day
|
|---|---|
|
Young Mania Rating Scale
|
-0.6 units on a scale
Interval -2.0 to 0.7
|
SECONDARY outcome
Timeframe: Baseline (week 0) - week 6The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Riluzole
n=14 Participants
Riluzole 100-200 mg/day
|
|---|---|
|
Clinical Global Impression Scale
|
-1.6 units on a scale
Interval -2.4 to -0.8
|
Adverse Events
Riluzole
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Riluzole
n=14 participants at risk
Riluzole 100-200 mg/day
|
|---|---|
|
Gastrointestinal disorders
nausea
|
42.9%
6/14 • Number of events 6
|
|
Nervous system disorders
headache
|
28.6%
4/14 • Number of events 4
|
|
Gastrointestinal disorders
diarrhea
|
28.6%
4/14 • Number of events 4
|
|
Nervous system disorders
insomnia
|
28.6%
4/14 • Number of events 4
|
|
Gastrointestinal disorders
constipation
|
21.4%
3/14 • Number of events 3
|
|
Nervous system disorders
sedation
|
21.4%
3/14 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
21.4%
3/14 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
dizziness
|
14.3%
2/14 • Number of events 2
|
|
General disorders
dry mouth
|
14.3%
2/14 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
back pain
|
14.3%
2/14 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place