Trial Outcomes & Findings for The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning (NCT NCT00566735)
NCT ID: NCT00566735
Last Updated: 2012-12-03
Results Overview
This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Participants were followed for the duration of hospital stay, an average of 3 weeks
Results posted on
2012-12-03
Participant Flow
Participant milestones
| Measure |
Placebo
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
Withdrew Before Baseline Measures
|
2
|
7
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Refused neuropsychological testing
|
2
|
5
|
|
Overall Study
Switched into a manic episode
|
0
|
1
|
Baseline Characteristics
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
n=12 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Wechsler Abbreviated Scale of Intelligence (WASI)
|
102.16 WASI Score
STANDARD_DEVIATION 18.21 • n=5 Participants
|
104.57 WASI Score
STANDARD_DEVIATION 12.35 • n=7 Participants
|
103.12 WASI Score
STANDARD_DEVIATION 15.87 • n=5 Participants
|
|
Hamilton Depression Rating Scale 17 (HAM-D-17)
|
27.33 HAM-D-17 Score
STANDARD_DEVIATION 4.33 • n=5 Participants
|
24.53 HAM-D-17 Score
STANDARD_DEVIATION 4.33 • n=7 Participants
|
26.21 HAM-D-17 Score
STANDARD_DEVIATION 4.33 • n=5 Participants
|
|
Subjective Mood
|
8.0 Subjective Mood Score
STANDARD_DEVIATION 1.54 • n=5 Participants
|
7.88 Subjective Mood Score
STANDARD_DEVIATION 1.93 • n=7 Participants
|
7.95 Subjective Mood Score
STANDARD_DEVIATION 1.70 • n=5 Participants
|
|
Clinical-Global Impressions - Severity (CGI-S)
|
4.75 CGI-S Score
STANDARD_DEVIATION 0.62 • n=5 Participants
|
4.41 CGI-S Score
STANDARD_DEVIATION 0.87 • n=7 Participants
|
4.61 CGI-S Score
STANDARD_DEVIATION .72 • n=5 Participants
|
|
Modified Mini Mental Status Exam (3MSE)
|
91.72 3MSE Score
STANDARD_DEVIATION 8.05 • n=5 Participants
|
90.41 3MSE Score
STANDARD_DEVIATION 5.48 • n=7 Participants
|
91.20 3MSE Score
STANDARD_DEVIATION 7.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of hospital stay, an average of 3 weeksThis measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.
Outcome measures
| Measure |
Placebo
n=18 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
n=12 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
|---|---|---|
|
Number of Side Effects
|
19 Number of reported side effects
|
13 Number of reported side effects
|
SECONDARY outcome
Timeframe: Participants were questioned at baseline and after their last electroconvulsive therapy treatmentThis measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.
Outcome measures
| Measure |
Placebo
n=18 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
n=12 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
|---|---|---|
|
Cognitive Functioning
Pre-ECT
|
80.33 Score on the DMI
Standard Deviation 17.87
|
88.75 Score on the DMI
Standard Deviation 15.64
|
|
Cognitive Functioning
Post-ECT
|
68.50 Score on the DMI
Standard Deviation 22.65
|
88.17 Score on the DMI
Standard Deviation 19.84
|
SECONDARY outcome
Timeframe: Participants were questioned at baselineThis measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with \<7 referring to mild-to-no depression, and \>23 referring to severe depression.
Outcome measures
| Measure |
Placebo
n=18 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
n=12 Participants
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
|---|---|---|
|
Baseline Depressive Symptoms
|
24.53 Score on the HAM-D-17
Standard Deviation 4.33
|
27.33 Score on the HAM-D-17
Standard Deviation 4.33
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Galantamine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
|
Galantamine
n=18 participants at risk
Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
|
|---|---|---|
|
General disorders
nausea
|
15.8%
3/19 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
|
General disorders
headache
|
26.3%
5/19 • Number of events 5
|
16.7%
3/18 • Number of events 3
|
|
General disorders
dizziness
|
21.1%
4/19 • Number of events 4
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
diarrhea
|
21.1%
4/19 • Number of events 4
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
vomiting
|
15.8%
3/19 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place