Trial · NCT01555697

Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia

NCT01555697, Phase 1, Phase 2, Completed, University of California, San Diego; results first posted 2020-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia. Trials, record NCT01555697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01555697

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia
NCT number: NCT01555697
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 80 participants, actual
Lead sponsor: University of California, San Diego
Conditions: Schizophrenia
Interventions: Memantine, Placebo
First posted: 2012-03-15
Last updated: 2022-10-04
Results first posted: 2020-08-10

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prepulse Inhibition	approx 45 minutes		% inhibition of startle	MEAN
SECONDARY	MATRICS	approx 1 hour		standardized T-score	MEAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Prepulse Inhibition	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine	Placebo	30.4	Standard Error 5.7	% inhibition of startle
Prepulse Inhibition	Healthy Subjects: Placebo 1st, Then 10 mg Memantine	Placebo	25.5	Standard Error 8.1	% inhibition of startle
Prepulse Inhibition	Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo	Placebo	23.7	Standard Error 6.0	% inhibition of startle
Prepulse Inhibition	Healthy Subjects: 10 mg Memantine 1st, Then Placebo	Placebo	2.6	Standard Error 19.2	% inhibition of startle
Prepulse Inhibition	Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine	Placebo	-1.7	Standard Error 9.9	% inhibition of startle
Prepulse Inhibition	Healthy Subjects: Placebo 1st, Then 20 mg Memantine	Placebo	-9.7	Standard Error 33.2	% inhibition of startle
Prepulse Inhibition	Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo	Placebo	34.2	Standard Error 8.7	% inhibition of startle
Prepulse Inhibition	Healthy Subjects: 20 mg Memantine 1st, Then Placebo	Placebo	12.1	Standard Error 7.3	% inhibition of startle
Prepulse Inhibition	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine	Memantine	28.9	Standard Error 6.8	% inhibition of startle
Prepulse Inhibition	Healthy Subjects: Placebo 1st, Then 10 mg Memantine	Memantine	27.3	Standard Error 6.5	% inhibition of startle

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine	10
Overall Study	STARTED	Healthy Subjects: Placebo 1st, Then 10 mg Memantine	10
Overall Study	STARTED	Subjects With Schizophrenia: 10 mg Memantine 1st, Then Placebo	10
Overall Study	STARTED	Healthy Subjects: 10 mg Memantine 1st, Then Placebo	10
Overall Study	STARTED	Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine	10
Overall Study	STARTED	Healthy Subjects: Placebo 1st, Then 20 mg Memantine	10
Overall Study	STARTED	Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo	10
Overall Study	STARTED	Healthy Subjects: 20 mg Memantine 1st, Then Placebo	10
Overall Study	6 Hours Lab Testing Day 1	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Memantine	10
Overall Study	6 Hours Lab Testing Day 1	Healthy Subjects: Placebo 1st, Then 10 mg Memantine	10

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Memantine	80
Total, all-cause mortality	Placebo	80
Total, other adverse events	Memantine	80
Total, other adverse events	Placebo	80
Total, serious adverse events	Memantine	80
Total, serious adverse events	Placebo	80

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Memantine vs Placebo: deaths from any cause	Trial comparisons
Memantine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01555697

GET https://conductscience.org/api/trials/v1/NCT01555697/results?page=2

API reference For AI assistants