Trial · NCT02953639
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
NCT02953639, Phase 2, Completed, Hoffmann-La Roche; results first posted 2021-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics. Trials, record NCT02953639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02953639
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
- NCT number
- NCT02953639
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 214 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Schizophrenia
- Interventions
- Basmisanil, Placebo
- First posted
- 2016-11-03
- Last updated
- 2021-02-09
- Results first posted
- 2021-02-09
- Limitations and caveats
- Following a planned futility analysis, enrolment into the 80mg Basmisanil arm was discontinued as of 8th November 2018. Results from the 80mg Basmisanil arm are thus not presented.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Baseline up to Week 24 | The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment. |
| Secondary | Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | Baseline up to Week 24 | The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher T-score represents lower impairment. |
| Secondary | Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score | Baseline up to Week 24 | The Paired Associates Learning (PAL I and II) of the WMS-IV (Wechsler Memory Scale Fourth edition) is a test of verbal learning and memory that requires the participant to learn novel word pairs. The participant learns the word pairs across learning trials and is asked to recall them immediately (PAL I) or after a 30-minute delay (PAL II). Data is presented here for 3 Scores: VPA I total raw score, VPA II total raw score and VPA II Recognition total raw score. The total raw score ranges for these 3 Scores are 0 to 56, 0 to 14 and 0 to 40 respectively, with larger total raw scores indicating better performance. |
| Secondary | Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score | Baseline up to Week 24 | Logical memory (LM) assesses narrative memory under free-recall conditions. Two short stories are presented orally. The examinee is asked to retell each story from memory immediately after hearing it (LM I). In the delayed condition (LM II), the examinee is asked to retell both stories from the immediate condition (delayed free recall). Data is presented here for 2 Scores: LM I total raw score and LM II total raw score. The total raw score range is from 0 to 50 with larger total raw scores indicating better performance. |
| Secondary | Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores | Baseline up to Week 24 | The TMT consists of two parts: Trail Making Part A, which is a part of the standard MCCB and Trail Making Part B additionally included in this study. Circles containing numbers (Part A) or both numbers and letters (Part B) must be sequentially connected. The difference (ratio) in performance between Part A and Part B reflects executive processes and will be used to assess executive functioning including cognitive set shifting abilities and data for this ratio is presented here. Smaller ratio values, hence decreases from baseline (TMT-B/TMT-A ratio values below 1) indicate higher executive functioning capabilities. |
| Secondary | Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score | Baseline up to Week 24 | The PSP Total Score is an integer result in the range of 0 to 100. Larger values, hence increases from baseline in the PSP total score, indicate higher social and personal functioning. |
| Secondary | Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score | Baseline up to Week 24 | The main parameter of interest for the Schizophrenia Cognition Rating Scale (SCoRS) is the SCoRS 'Total Score'. The total score range is from 0 to 80 with lower scores indicating better day-to-day functioning. |
| Secondary | Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating | Baseline up to Week 24 | Values for the CGI-S Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment. |
| Secondary | Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating | Baseline up to Week 24 | Values for the CGI-I Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment. |
| Secondary | Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS) | Baseline up to Week 24 | The SQLS is a patient reported scale consisting of 33 items: 2 domain scores (Cognition \& Vitality Score \[SQLS-CV\] and Psycho-social Score \[SQLS-P\]) as well as a Total score (SQLS-T) are derived. The overall score range is from 0 to 100. On all scales, higher scores represent a lower quality of life. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Composite T-Score | MEAN |
| SECONDARY | Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | T-score | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Ratio | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS) | Baseline up to Week 24 | The EAP2 Population was defined as all participants in the Efficacy Analysis Population (EAP) who were randomized to placebo or 240mg Basmisanil (excluded participants randomized to 80mg Basmisanil due to the results of a futility analysis which meant that enrolment into the 80mg Basmisanil arm was discontinued). Data presented below is only for participants that were included in the actual analysis. | Scores on a Scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group131
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Placebo | Baseline | 32.50 | Standard Deviation 14.47 | Composite T-Score |
| Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Basmisanil 240mg BID | Baseline | 32.36 | Standard Deviation 11.44 | Composite T-Score |
| Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Placebo | Week 12 Day 84 | -0.17 | Standard Deviation 5.07 | Composite T-Score |
| Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Basmisanil 240mg BID | Week 12 Day 84 | -0.28 | Standard Deviation 6.08 | Composite T-Score |
| Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Placebo | Week 24 Day 168 | 1.08 | Standard Deviation 5.78 | Composite T-Score |
| Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score | Basmisanil 240mg BID | Week 24 Day 168 | 1.36 | Standard Deviation 4.80 | Composite T-Score |
| Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | Placebo | Baseline (Attention/Vigilance) | 40.75 | Standard Deviation 12.31 | T-score |
| Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | Basmisanil 240mg BID | Baseline (Attention/Vigilance) | 39.66 | Standard Deviation 12.08 | T-score |
| Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | Placebo | Week 12 Day 84 (Attention/Vigilance) | -0.16 | Standard Deviation 8.00 | T-score |
| Change From Baseline to Week 24 in MCCB Cognitive Domain Scores | Basmisanil 240mg BID | Week 12 Day 84 (Attention/Vigilance) | -0.14 | Standard Deviation 8.80 | T-score |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 81 | |
| Overall Study | STARTED | Basmisanil 80mg BID | 54 | |
| Overall Study | STARTED | Basmisanil 240mg BID | 78 | |
| Overall Study | COMPLETED | Placebo | 61 | |
| Overall Study | COMPLETED | Basmisanil 80mg BID | 40 | |
| Overall Study | COMPLETED | Basmisanil 240mg BID | 62 | |
| Overall Study | NOT COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Basmisanil 80mg BID | 14 | |
| Overall Study | NOT COMPLETED | Basmisanil 240mg BID | 16 |
Source ClinicalTrials.gov
Adverse events36
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 | Placebo | 4 | 81 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Basmisanil 80mg BID | 3 | 54 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Basmisanil 240mg BID | 2 | 78 | 2 |
| other | Fatigue | General disorders | Placebo | 6 | 81 | 7 |
| other | Fatigue | General disorders | Basmisanil 80mg BID | 1 | 54 | 1 |
| other | Fatigue | General disorders | Basmisanil 240mg BID | 1 | 78 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 0 | 81 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Basmisanil 80mg BID | 3 | 54 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Basmisanil 240mg BID | 0 | 78 | 0 |
| other | Headache | Nervous system disorders | Placebo | 1 | 81 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 81 |
| Total, all-cause mortality | Basmisanil 80mg BID | 0 | 54 |
| Total, all-cause mortality | Basmisanil 240mg BID | 0 | 78 |
| Total, other adverse events | Placebo | 10 | 81 |
| Total, other adverse events | Basmisanil 80mg BID | 10 | 54 |
| Total, other adverse events | Basmisanil 240mg BID | 12 | 78 |
| Total, serious adverse events | Placebo | 5 | 81 |
| Total, serious adverse events | Basmisanil 80mg BID | 0 | 54 |
| Total, serious adverse events | Basmisanil 240mg BID | 4 | 78 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41983730 | 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.
Tests6
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 |
|---|---|---|
| Delayed Recall Module | Secondary outcome | ConductCognition |
| Paired Associate Learning | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Word Pair Learning | 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/NCT02953639
GET https://conductscience.org/api/trials/v1/NCT02953639/results?page=2