Swerdlow-R34: Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia
Study Details
Study Description
Brief Summary
Cognitive training is moderately effective at reducing symptoms and improving life function in schizophrenia patients. The present application develops a strategy for increasing the effectiveness of cognitive training through the use of pro-cognitive medications. Specific biomarkers will be studied that identify patients most sensitive to these pro-cognitive medications, to test the feasibility of using these biomarkers in a large clinical trial of medication-enhanced cognitive training in schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This R34 application responds to PAR-09-173, to achieve the first goal of this FOA by supporting: "the development and/or pilot testing of new or adapted interventions." The two overarching goals of this application are: 1) to test the effects of the acute administration of the NMDA antagonist, memantine (MEM), on sensorimotor gating and working memory (WM) in schizophrenia (SZ) patients, and 2) to assess the feasibility of using MEM to predictably enhance the therapeutic benefits of cognitive training in SZ.
The pharmacotherapy of SZ has been dominated by antidopaminergic drugs with limited clinical impact. Some forms of psychosocial rehabilitation, such as cognitive training (CT), appear to effectively reduce symptoms and improve function in SZ. The premise of this application is that the benefits of CT in SZ might be enhanced by drugs that increase specific cognitive abilities, including WM, even if these pro-cognitive drugs lack clinical impact when administered without CT. The main goal of this application is to develop an innovative intervention strategy that enhances the clinical benefits of CT in SZ through administration of a pro-cognitive agent to biomarker-identified sensitive patients.
The investigators reported that a single dose of the widely used Alzheimer's disease medication, MEM (20 mg p.o.), significantly increased prepulse inhibition (PPI) of the startle reflex in healthy subjects. PPI-enhancing effects of MEM in healthy subjects are associated with: 1) increased WM; and 2) phenotypes linked to the high activity Val158Met COMT polymorphism. PPI is consistently impaired in SZ patients; lowest levels of PPI in patients are associated with: 1) poor functional outcome; and 2) the Val/Val COMT genotype. If our MEM findings in healthy subjects are reproduced in SZ patients, the investigators will detect MEM-associated improvements in PPI and WM, particularly among Val/Val patients. The investigators will then be positioned to test the hypothesis that acute PPI and WM-enhancing effects of MEM predict therapeutic benefit of MEM in SZ patients undergoing CT.
This application has two aims: Aim 1 will assess the acute effects of MEM (0 vs. 10 or 0 vs. 20 mg p.o.) in 60 SZ patients, to test the prediction that MEM will increase PPI and enhance WM in SZ patients, particularly in those characterized by low basal PPI levels and/or the Val/Val COMT genotype. Mismatch negativity and gamma band synchronization will also be assessed as potentially informative MEM-sensitive and functionally relevant biomarkers. Aim 2 will assess the feasibility of testing the therapeutic benefit of MEM as an adjunct to CT in SZ patients, and the feasibility of testing the primary hypothesis that such benefit will be predicted by increased PPI and/or WM in SZ patients after the Aim 1 single dose MEM challenge. It is predicted that subject recruitment and completion in both arms of a controlled 12-week CT trial in SZ out-patients among subjects completing Aim 1 will be appropriate for testing both the overall effectiveness of MEM as an adjunct to CT and the ability to predict this effectiveness among biomarker-identified patient subgroups.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Memantine/high memantine 20 mg |
Drug: Memantine
Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Other Names:
|
| Placebo Comparator: Placebo/high placebo comparator for memantine 20 mg |
Drug: Placebo
Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
|
| Active Comparator: Memantine/low memantine 10 mg |
Drug: Memantine
Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Other Names:
|
| Placebo Comparator: Placebo/low placebo comparator for memantine 10 mg |
Drug: Placebo
Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
|
Outcome Measures
Primary Outcome Measures
- Prepulse Inhibition [approx 45 minutes]
Prepulse inhibition of the startle reflex is the automatic reduction in startle magnitude (assessed here by EMG of orbicularis oculi) when a startling stimulus (here a 40 ms 118 dB(A) noise burst; "PULSE") is preceded (here 10 - 120 msec) by a weak stimulus (here a 20 msec burst 16 dB over background "PREPULSE"). A %PPI metric is calculated based on the relative startle magnitude on (PREPULSE + PULSE) trials vs. PULSE alone trials. Possible maximal inhibition is 100%; there is no maximal "negative" value of inhibition. There is no clear "advantage" or "disadvantage" for lower or higher %PPI values, though on average, schizophrenia patients demonstrate lower % values compared to matched healthy subjects.
Secondary Outcome Measures
- MATRICS [approx 1 hour]
MATRICS Consensus Cognitive Battery Performance: This is a standardized neurocognitive battery that assesses performance in 7 domains of neurocognition. Primary data are recorded based on normalized T-scores; a separate score is provided for each domain, and a Comprehensive score (Primary measure here) is also calculated across domains. Possible T-score range is 0 - 100; higher score reflects better performance.
Eligibility Criteria
Criteria
Inclusion Criteria:
- A diagnosis of schizophrenia or schizoaffective disorder - depressed type
Exclusion Criteria:
-
Age range,
-
Current alcohol or drug abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Diego | San Diego | California | United States | 92103 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- NIMH-R34-MH093453-NS
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine | Healthy Subjects: Placebo 1st, Then 10 mg Memantine | Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo | Healthy Subjects: 10 mg Memantine 1st, Then Placebo | Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine | Healthy Subjects: Placebo 1st, Then 20 mg Memantine | Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo | Healthy Subjects: 20 mg Memantine 1st, Then Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. |
| Period Title: Overall Study | ||||||||
| STARTED | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 6 Hours Lab Testing Day 1 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| Approx 7 Day Washout | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| 6 Hours Lab Testing Day 2 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| COMPLETED | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine | Healthy Subjects: Placebo 1st, Then 10 mg Memantine | Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo | Healthy Subjects: 10 mg Memantine 1st, Then Placebo | Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine | Healthy Subjects: Placebo 1st, Then 20 mg Memantine | Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo | Healthy Subjects: 20 mg Memantine 1st, Then Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | Total of all reporting groups |
| Overall Participants | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 80 |
| Age (Count of Participants) | |||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
80
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Full Range) ] | |||||||||
| Mean (Full Range) [years] |
32.4
|
26.4
|
39.2
|
32.0
|
38.9
|
29.6
|
35.7
|
23.8
|
32
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
2
20%
|
1
10%
|
2
20%
|
2
20%
|
4
40%
|
4
40%
|
4
40%
|
3
30%
|
22
27.5%
|
| Male |
8
80%
|
9
90%
|
8
80%
|
8
80%
|
6
60%
|
6
60%
|
6
60%
|
7
70%
|
58
72.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
2
20%
|
2
20%
|
2
20%
|
1
10%
|
3
30%
|
1
10%
|
2
20%
|
5
50%
|
18
22.5%
|
| Not Hispanic or Latino |
8
80%
|
8
80%
|
7
70%
|
9
90%
|
7
70%
|
9
90%
|
8
80%
|
5
50%
|
61
76.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.3%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||
| American Indian or Alaska Native |
1
10%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
10%
|
3
3.8%
|
| Asian |
2
20%
|
4
40%
|
0
0%
|
0
0%
|
0
0%
|
4
40%
|
3
30%
|
3
30%
|
16
20%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.3%
|
| Black or African American |
3
30%
|
0
0%
|
0
0%
|
2
20%
|
5
50%
|
0
0%
|
2
20%
|
2
20%
|
14
17.5%
|
| White |
3
30%
|
5
50%
|
8
80%
|
7
70%
|
4
40%
|
5
50%
|
3
30%
|
3
30%
|
38
47.5%
|
| More than one race |
0
0%
|
0
0%
|
1
10%
|
0
0%
|
0
0%
|
0
0%
|
1
10%
|
0
0%
|
2
2.5%
|
| Unknown or Not Reported |
1
10%
|
0
0%
|
1
10%
|
1
10%
|
1
10%
|
1
10%
|
0
0%
|
1
10%
|
6
7.5%
|
| Region of Enrollment (participants) [Number] | |||||||||
| United States |
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
10
100%
|
80
100%
|
Outcome Measures
| Title | Prepulse Inhibition |
|---|---|
| Description | Prepulse inhibition of the startle reflex is the automatic reduction in startle magnitude (assessed here by EMG of orbicularis oculi) when a startling stimulus (here a 40 ms 118 dB(A) noise burst; "PULSE") is preceded (here 10 - 120 msec) by a weak stimulus (here a 20 msec burst 16 dB over background "PREPULSE"). A %PPI metric is calculated based on the relative startle magnitude on (PREPULSE + PULSE) trials vs. PULSE alone trials. Possible maximal inhibition is 100%; there is no maximal "negative" value of inhibition. There is no clear "advantage" or "disadvantage" for lower or higher %PPI values, though on average, schizophrenia patients demonstrate lower % values compared to matched healthy subjects. |
| Time Frame | approx 45 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine | Healthy Subjects: Placebo 1st, Then 10 mg Memantine | Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo | Healthy Subjects: 10 mg Memantine 1st, Then Placebo | Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine | Healthy Subjects: Placebo 1st, Then 20 mg Memantine | Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo | Healthy Subjects: 20 mg Memantine 1st, Then Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| Placebo |
30.4
(5.7)
|
25.5
(8.1)
|
23.7
(6.0)
|
2.6
(19.2)
|
-1.7
(9.9)
|
-9.7
(33.2)
|
34.2
(8.7)
|
12.1
(7.3)
|
| Memantine |
28.9
(6.8)
|
27.3
(6.5)
|
-0.9
(13.7)
|
31.1
(8.1)
|
26.1
(7.8)
|
29.9
(8.4)
|
40.1
(7.1)
|
14.6
(5.7)
|
| Title | MATRICS |
|---|---|
| Description | MATRICS Consensus Cognitive Battery Performance: This is a standardized neurocognitive battery that assesses performance in 7 domains of neurocognition. Primary data are recorded based on normalized T-scores; a separate score is provided for each domain, and a Comprehensive score (Primary measure here) is also calculated across domains. Possible T-score range is 0 - 100; higher score reflects better performance. |
| Time Frame | approx 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine | Healthy Subjects: Placebo 1st, Then 10 mg Memantine | Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo | Healthy Subjects: 10 mg Memantine 1st, Then Placebo | Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine | Healthy Subjects: Placebo 1st, Then 20 mg Memantine | Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo | Healthy Subjects: 20 mg Memantine 1st, Then Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 10 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 10 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participant in this arm receive a single pill of placebo followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single 20 mg pill of memantine and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Schizophrenia subjects in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. | This is a crossover design with 2 active doses used as between-subject factors. Healthy participants in this arm receive a single 20 mg pill of memantine followed by about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of placebo and is again tested in the laboratory. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| Placebo |
40.4
(3.8)
|
53.4
(2.3)
|
41.1
(3.8)
|
56.3
(2.4)
|
34.2
(4.4)
|
48.6
(4.3)
|
37.7
(4.6)
|
66.6
(2.0)
|
| Memantine |
44.6
(4.5)
|
60.2
(2.7)
|
34.3
(3.3)
|
56.6
(6.6)
|
35.8
(4.8)
|
53.7
(5.8)
|
31.0
(4.5)
|
57.6
(1.9)
|
Adverse Events
| Time Frame | 2 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Memantine | Placebo | ||
| Arm/Group Description | Memantine: Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. | Placebo: Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. | ||
All Cause Mortality |
||||
| Memantine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | 0/80 (0%) | ||
Serious Adverse Events |
||||
| Memantine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | 0/80 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Memantine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | 0/80 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Neal Swerdlow, M.D., Ph.D. |
|---|---|
| Organization | UC San Diego |
| Phone | 619-543-6270 |
| nswerdlow@health.ucsd.edu |
- NIMH-R34-MH093453-NS