Trial · NCT01889602

Characterizing and Predicting Drug Effects on Cognition

NCT01889602, Phase 4, Completed, University of Minnesota; results first posted 2019-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Characterizing and Predicting Drug Effects on Cognition. Trials, record NCT01889602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01889602

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Trial

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

Title: Characterizing and Predicting Drug Effects on Cognition
NCT number: NCT01889602
Status: Completed
Phases: Phase 4
Enrollment: 60 participants, actual
Lead sponsor: University of Minnesota
Conditions: Cognitive Deficits
Interventions: Lorazepam, Placebo, Topiramate 100mg, Topiramate 150mg, Topiramate 200mg
First posted: 2013-06-28
Last updated: 2019-12-17
Results first posted: 2019-12-17

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in COWA Unique Word Count	Session 1 to Session 5	Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value at baseline, divided by the value at baseline; similarly for Lorazepam and Placebo.
Primary	Change From Baseline in Spontaneous Narrative Raw Word Count	Session 1 to Session 5	Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value at baseline, divided by the value at baseline; similarly for Lorazepam and Placebo.

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	Change From Baseline in COWA Unique Word Count	Session 1 to Session 5		Word Count	MEAN
PRIMARY	Change From Baseline in Spontaneous Narrative Raw Word Count	Session 1 to Session 5		Word Count	MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 100mg, Period: Topiramate	-0.407725385	Standard Deviation 0.110593408	Word Count
Change From Baseline in COWA Unique Word Count	Arm:Topiramate 150mg, Period: Topiramate	-0.425898667	Standard Deviation 0.186240451	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 200mg, Period: Topiramate	-0.412534118	Standard Deviation 0.154640084	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 100mg, Period: Lorazepam	-0.108298333	Standard Deviation 0.240452491	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 150mg, Period: Lorazepam	0.131452143	Standard Deviation 0.263967943	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 200mg, Period: Lorazepam	-0.095221176	Standard Deviation 0.228163172	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 100mg, Period: Placebo	-0.011651538	Standard Deviation 0.152526619	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 150mg, Period: Placebo	0.077431333	Standard Deviation 0.176020802	Word Count
Change From Baseline in COWA Unique Word Count	Arm: Topiramate 200mg, Period: Placebo	0.047164706	Standard Deviation 0.166162762	Word Count
Change From Baseline in Spontaneous Narrative Raw Word Count	Arm: Topiramate 100mg, Period: Topiramate	-0.01596	Standard Deviation 0.360237984	Word Count

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow54

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

Period	Milestone	Group	Participants
First Intervention	STARTED	Topiramate 100mg	20
First Intervention	STARTED	Topiramate 150mg	20
First Intervention	STARTED	Topiramate 200mg	20
First Intervention	COMPLETED	Topiramate 100mg	19
First Intervention	COMPLETED	Topiramate 150mg	17
First Intervention	COMPLETED	Topiramate 200mg	18
First Intervention	NOT COMPLETED	Topiramate 100mg	1
First Intervention	NOT COMPLETED	Topiramate 150mg	3
First Intervention	NOT COMPLETED	Topiramate 200mg	2
First Washout Period of at Least 2 Weeks	STARTED	Topiramate 100mg	19

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events5

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

Type	Event	Organ system	Group	Affected	At risk	Events
other	Eye Twitching	Eye disorders	Topiramate 100mg	0	14	0
other	Eye Twitching	Eye disorders	Topiramate 150mg	0	15	0
other	Eye Twitching	Eye disorders	Topiramate 200mg	1	17	1
other	Eye Twitching	Eye disorders	Lorazepam 2mg	0	46	0
other	Eye Twitching	Eye disorders	Placebo	0	46	0

Source ClinicalTrials.gov

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topiramate 100mg	0	14
Total, all-cause mortality	Topiramate 150mg	0	15
Total, all-cause mortality	Topiramate 200mg	0	17
Total, all-cause mortality	Lorazepam 2mg	0	46
Total, all-cause mortality	Placebo	0	46
Total, other adverse events	Topiramate 100mg	0	14
Total, other adverse events	Topiramate 150mg	0	15
Total, other adverse events	Topiramate 200mg	1	17
Total, other adverse events	Lorazepam 2mg	0	46
Total, other adverse events	Placebo	0	46

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32297992	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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/NCT01889602

GET https://conductscience.org/api/trials/v1/NCT01889602/flow?page=2

API reference For AI assistants