Trial Outcomes & Findings for Memantine Augmentation of Antidepressants (NCT NCT00344682)
NCT ID: NCT00344682
Last Updated: 2018-07-11
Results Overview
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in MADRS score was a primary measure.
COMPLETED
PHASE4
31 participants
Baseline & week 8
2018-07-11
Participant Flow
Study participants were recruited through clinician referral and posted and radio advertising with the majority of patients recruited through clinician referral within our single-site, tertiary-care medical center.
Participants continued on their previously prescribed antidepressant at the same dose throughout the study.
Participant milestones
| Measure |
Placebo
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Memantine Augmentation of Antidepressants
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 Participants
memantine : memantine 5mg - 20mg PO daily
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
49.75 years
STANDARD_DEVIATION 11.68 • n=99 Participants
|
54.8 years
STANDARD_DEVIATION 6.17 • n=107 Participants
|
52.28 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
15 participants
n=107 Participants
|
31 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline & week 8Population: The primary outcome examines a mean change in MADRS scores at baseline \& week 8 through last observation carried forward (LOCF); no values were imputed for missing assessments. The primary data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in MADRS score was a primary measure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 Participants
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Score (MADRS)
|
-7.25 units on a scale
Standard Deviation 11.14
|
-7.13 units on a scale
Standard Deviation 6.61
|
SECONDARY outcome
Timeframe: baseline & week 8Population: The secondary outcome examines a change over in mean QID-SR scores at baseline \& week 8 through last observed data carried forward (LOCF); no values were imputed for missing assessments. Data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.
The 16 item Quick Inventory of Depressive Symptomatology (QIDS-SR16) (Rush et al. 2003) is designed to assess the severity of depressive symptoms, with higher scores representing more severe forms of depression. When complete, the QIDS are scored by summing responses to obtain a total score ranging from 0 to 27. Either appetite increase or decrease, but not both, are used to calculate the total score. Weight increase or decrease, but not both, are used to calculate the total score. Scores 0-5 indicate no severity of depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; 21-27 is very severe levels of depression. Participants were evaluated at baseline and at weeks 1, 2, 3, 4, 6 \& 8.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 Participants
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Modified Quick Inventory of Depressive Symptoms Self Report Scale (QIDS-SR)
|
-3.69 units on a scale
Standard Deviation 5.00
|
-6.47 units on a scale
Standard Deviation 5.25
|
SECONDARY outcome
Timeframe: baseline & week 8Population: Secondary outcome examines a change in mean HARS scores observed at baseline \& week 8 through last observed data carried forward (LOCF);no values were imputed for missing assessments.Efficacy data analysis used intent-to-treat measures \& computes final study score minus baseline averaged among participants to evaluate treatment group differences
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Scores \> 30 indicate severe anxiety.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 Participants
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Hamilton Anxiety Rating Scale (HARS)
|
-4.13 units on a scale
Standard Deviation 5.11
|
-5.53 units on a scale
Standard Deviation 7.29
|
SECONDARY outcome
Timeframe: baseline and week 8Population: Secondary outcome examines a change in response rates,when 50% change from baseline, \& remission rates, when MADRS scores of 12 or less were observed.Fischer exact tests assessed efficiency in each treatment group. Intent-to-treat rates at baseline minus week 8 through last observed data carried forward (LOCF) were used;no data values were imputed
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6 on 10 items. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in response rate and remission rate were assessed for secondary measures.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 Participants
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Score (MADRS)
|
-10.75 units on a scale
Standard Deviation 10.46
|
-7.13 units on a scale
Standard Deviation 6.11
|
Adverse Events
Placebo
Memantine
Serious adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 participants at risk
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
6.2%
1/16 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo comparator : 5mg - 20mg PO daily over 8 weeks
|
Memantine
n=15 participants at risk
memantine : memantine 5mg - 20mg PO daily
|
|---|---|---|
|
Psychiatric disorders
anxiety
|
18.8%
3/16 • Number of events 3
|
20.0%
3/15 • Number of events 3
|
|
Psychiatric disorders
irritability
|
12.5%
2/16 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place