Trial · NCT00487942
Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
NCT00487942, Phase 2, Completed, Cephalon; results first posted 2010-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits. Trials, record NCT00487942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00487942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
- NCT number
- NCT00487942
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Schizophrenia
- Interventions
- armodafinil, armodafinil, armodafinil, placebo
- First posted
- 2007-06-19
- Last updated
- 2013-07-19
- Results first posted
- 2010-12-20
Source ClinicalTrials.gov
Registered outcomes94
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score. |
| Secondary | Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score | Baseline and 4 weeks | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline 4 weeks (or last observation after baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after baseline) | The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline. |
| Secondary | Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline. |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 registered outcomesOutcomes94
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score | Baseline and 4 weeks | Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline 4 weeks (or last observation after baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Baseline and 4 weeks (or last observation after Baseline) | Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated. | Units on a scale | MEAN |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 outcomesResults by group592
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Armodafinil 50 mg/Day | 1.9 | Standard Deviation 6.22 | Units on a scale | |
| Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Armodafinil 100 mg/Day | 2.8 | Standard Deviation 7.98 | Units on a scale | |
| Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Armodafinil 200 mg/Day | 2.9 | Standard Deviation 4.72 | Units on a scale | |
| Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Placebo | 2.2 | Standard Deviation 5.06 | Units on a scale | |
| Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score | Armodafinil 50 mg/Day | 2.2 | Standard Deviation 6.13 | Units on a scale | |
| Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score | Armodafinil 100 mg/Day | 3.9 | Standard Deviation 5.99 | Units on a scale | |
| Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score | Armodafinil 200 mg/Day | 2.9 | Standard Deviation 4.72 | Units on a scale | |
| Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score | Placebo | 2.1 | Standard Deviation 5.28 | Units on a scale | |
Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Armodafinil 50 mg/Day | 3.0 | Standard Deviation 8.81 | Units on a scale | |
Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery | Armodafinil 100 mg/Day | 0.0 | Standard Deviation 10.42 | Units on a scale |
1 to 10 of 592Source ClinicalTrials.gov
See all 592 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Armodafinil 50 mg/Day | 15 | |
| Overall Study | STARTED | Armodafinil 100 mg/Day | 15 | |
| Overall Study | STARTED | Armodafinil 200 mg/Day | 15 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Armodafinil 50 mg/Day | 12 | |
| Overall Study | COMPLETED | Armodafinil 100 mg/Day | 12 | |
| Overall Study | COMPLETED | Armodafinil 200 mg/Day | 12 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | Armodafinil 50 mg/Day | 3 | |
| Overall Study | NOT COMPLETED | Armodafinil 100 mg/Day | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events168
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 | Diarrhoea | Gastrointestinal disorders | Armodafinil 50 mg/Day | 2 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Armodafinil 100 mg/Day | 2 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Armodafinil 200 mg/Day | 1 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 14 | |
| other | Dry mouth | Gastrointestinal disorders | Armodafinil 50 mg/Day | 0 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Armodafinil 100 mg/Day | 1 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Armodafinil 200 mg/Day | 1 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 14 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Armodafinil 50 mg/Day | 0 | 15 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Armodafinil 100 mg/Day | 2 | 15 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Armodafinil 50 mg/Day | ||
| Total, all-cause mortality | Armodafinil 100 mg/Day | ||
| Total, all-cause mortality | Armodafinil 200 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Armodafinil 50 mg/Day | 8 | 15 |
| Total, other adverse events | Armodafinil 100 mg/Day | 6 | 15 |
| Total, other adverse events | Armodafinil 200 mg/Day | 8 | 15 |
| Total, other adverse events | Placebo | 7 | 14 |
| Total, serious adverse events | Armodafinil 50 mg/Day | 0 | 15 |
| Total, serious adverse events | Armodafinil 100 mg/Day | 0 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20816042 | 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.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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/NCT00487942
GET https://conductscience.org/api/trials/v1/NCT00487942/registered?page=2