Trial Outcomes & Findings for Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression (NCT NCT00305578)
NCT ID: NCT00305578
Last Updated: 2016-07-18
Results Overview
Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
8 weeks
Results posted on
2016-07-18
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo daily
Placebo : No active medication, only placebo
|
Memantine
Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Placebo daily
Placebo : No active medication, only placebo
|
Memantine
n=14 Participants
Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 14 • n=93 Participants
|
38 years
STANDARD_DEVIATION 15 • n=4 Participants
|
40 years
STANDARD_DEVIATION 15 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
14 participants
n=4 Participants
|
29 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeksScale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo daily
Placebo : No active medication, only placebo
|
Memantine
n=14 Participants
Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
|
|---|---|---|
|
Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)
|
7 units on a scale
Standard Deviation 6
|
9 units on a scale
Standard Deviation 7
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Memantine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Placebo daily
Placebo : No active medication, only placebo
|
Memantine
n=14 participants at risk
Daily dose Memantine
Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.
|
|---|---|---|
|
Nervous system disorders
somnolence
|
33.3%
5/15 • Number of events 7
|
21.4%
3/14 • Number of events 6
|
|
Nervous system disorders
shakiness
|
6.7%
1/15 • Number of events 2
|
0.00%
0/14
|
|
Nervous system disorders
blurred vision
|
0.00%
0/15
|
14.3%
2/14 • Number of events 4
|
|
Nervous system disorders
headache
|
26.7%
4/15 • Number of events 6
|
21.4%
3/14 • Number of events 7
|
|
Nervous system disorders
sharper sense of smell
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
difficulty concentrating
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
fatigue
|
6.7%
1/15 • Number of events 3
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
muscle twitching
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
nocturnal sweating
|
0.00%
0/15
|
7.1%
1/14 • Number of events 8
|
|
Nervous system disorders
muscle weakness and muscle spasms
|
6.7%
1/15 • Number of events 1
|
7.1%
1/14 • Number of events 2
|
|
Nervous system disorders
dizziness
|
6.7%
1/15 • Number of events 3
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
dry mouth
|
20.0%
3/15 • Number of events 4
|
7.1%
1/14 • Number of events 3
|
|
Nervous system disorders
insomnia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
restlessness
|
6.7%
1/15 • Number of events 4
|
0.00%
0/14
|
|
Nervous system disorders
crawling skin
|
6.7%
1/15 • Number of events 2
|
0.00%
0/14
|
|
Nervous system disorders
feeling hot
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
gas
|
6.7%
1/15 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
indigestion
|
6.7%
1/15 • Number of events 4
|
14.3%
2/14 • Number of events 3
|
|
Gastrointestinal disorders
constipation
|
6.7%
1/15 • Number of events 1
|
7.1%
1/14 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/15
|
14.3%
2/14 • Number of events 4
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
6.7%
1/15 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
decreased appetite
|
0.00%
0/15
|
7.1%
1/14 • Number of events 7
|
|
Cardiac disorders
chest pain and chest tightness,
|
13.3%
2/15 • Number of events 5
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
high blood pressure
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
increased libido
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
coughing
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Endocrine disorders
breast discharge
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
|
Immune system disorders
swollen lymph nodes
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place