Trial · NCT01173874
Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone
NCT01173874, Phase 3, Completed, New York State Psychiatric Institute; results first posted 2017-04-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone. Trials, record NCT01173874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01173874
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone
- NCT number
- NCT01173874
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Schizophrenia
- Interventions
- Cognitive Remediation
- First posted
- 2010-08-02
- Last updated
- 2017-04-11
- Results first posted
- 2017-04-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cognitive Function Measured by MCCB Composite Score | 4-6 month period | The MATRICS Consensus Cognitive Battery (MCCB) will be used to assess cognitive function. The MCCB composite score is comprised of sub-scale measures of: a) working memory; b) attention and vigilance; c) verbal learning; d) visual learning; e) speed of processing; f) reason and problem solving; and g) social cognition. The MCCB takes 90 minutes or less to complete. MCCB assessed 4 times: prestabilization (screening), randomization (after 6-8 weeks of lurasidone stabilization, prior to initial cognitive remediation), midpoint (after 20 cognitive remediation session), and study completion (final visit after 30 cognitive remediation sessions). MCCB composite scores are reported as t-scores where a t-score = 50 is the population average. Every 10 points is one standard deviation. There is no range as scores are as far from population average. |
| Primary | Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale | 4-6 month period | The UPSA-B assesses functional capacity to perform tasks similar to those in daily life. Raw scores are converted into scaled scores ranging from 0-100, with higher scores indicating better functional capacity. |
| Secondary | Cognition as Measured by Cognitive Assessment Interview (CAI) | 4-6 month period | Cognitive Assessment Interview was used to obtain information about cognitive functioning from both subject and an informant. Composite CAI scores were reported. Scale ranges from 1-7 with the following anchors: 1. Normal, no cognitive impairment 2. Borderline impairment 3. Mildly impaired 4. Moderately impaired 5. Markedly impaired 6. Severely impaired 7. Among the most extremely impaired |
| Secondary | Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS) | 4-6 month period | Total PANSS score with 30 items. Each item is rated 1-7 so the minimum Total PANSS score =30 and the maximum is 210. Anchors for each item are as follows, the higher values represent an increase in severity of symptoms: 1. Absent 2. Minimal 3. Mild 4. Moderate 5. Moderately severe 6. Severe 7. Extremely severe |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cognitive Function Measured by MCCB Composite Score | 4-6 month period | Completers | units on a scale | MEAN |
| PRIMARY | Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale | 4-6 month period | Completed subjects | units on a scale | MEAN |
| SECONDARY | Cognition as Measured by Cognitive Assessment Interview (CAI) | 4-6 month period | completed subjects with available completed CAI data. Numbers above are correct as not all completed subjects (Analysis Population Description) had completed CAI assessment available for analysis. | units on a scale | MEAN |
| SECONDARY | Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS) | 4-6 month period | Completed subjects | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cognitive Function Measured by MCCB Composite Score | Cognitive Remediation | 35.39 | Standard Deviation 11.99 | units on a scale | |
| Cognitive Function Measured by MCCB Composite Score | Cognitive Activity Control Group | 30.73 | Standard Deviation 14.97 | units on a scale | |
| Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale | Cognitive Remediation | 79.74 | Standard Deviation 10.99 | units on a scale | |
| Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale | Cognitive Activity Control Group | 75.85 | Standard Deviation 16.37 | units on a scale | |
| Cognition as Measured by Cognitive Assessment Interview (CAI) | Cognitive Remediation | 2.74 | Standard Deviation 1.6 | units on a scale | |
| Cognition as Measured by Cognitive Assessment Interview (CAI) | Cognitive Activity Control Group | 2.79 | Standard Deviation 1.18 | units on a scale | |
| Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS) | Cognitive Remediation | 58.79 | Standard Deviation 14.71 | units on a scale | |
| Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS) | Cognitive Activity Control Group | 61.1 | Standard Deviation 17.29 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cognitive Remediation | 56 | |
| Overall Study | STARTED | Cognitive Activity Control Group | 64 | |
| Overall Study | COMPLETED | Cognitive Remediation | 33 | |
| Overall Study | COMPLETED | Cognitive Activity Control Group | 41 | |
| Overall Study | NOT COMPLETED | Cognitive Remediation | 23 | |
| Overall Study | NOT COMPLETED | Cognitive Activity Control Group | 23 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Exacerbation | Nervous system disorders | Cognitive Remediation | 4 | 56 | 5 |
| serious | Exacerbation | Nervous system disorders | Cognitive Activity Control Group | 6 | 64 | 7 |
| serious | abnormal ECG | Cardiac disorders | Cognitive Remediation | 1 | 56 | 1 |
| serious | abnormal ECG | Cardiac disorders | Cognitive Activity Control Group | 1 | 64 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cognitive Remediation | ||
| Total, all-cause mortality | Cognitive Activity Control Group | ||
| Total, other adverse events | Cognitive Remediation | 0 | 56 |
| Total, other adverse events | Cognitive Activity Control Group | 0 | 64 |
| Total, serious adverse events | Cognitive Remediation | 5 | 56 |
| Total, serious adverse events | Cognitive Activity Control Group | 7 | 64 |
Source ClinicalTrials.gov
Papers34
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cognitive Remediation vs Cognitive Activity Control Group: serious adverse events |
Source 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.
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/NCT01173874
GET https://conductscience.org/api/trials/v1/NCT01173874/papers?page=2