Trial · NCT02953639
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. |
| Secondary | Apparent Clearance of Basmisanil at Steady State (CL/F,ss) | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | Population PK model estimated apparent oral clearance of Basmisanil at steady-state. |
| Secondary | Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss) | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | Population PK model estimated apparent volume of distribution of Basmisanil at steady-state. |
| Secondary | Area Under the Curve of Basmisanil at Steady State (AUC,ss) | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | Population PK model estimated AUC of Basmisanil at steady-state. |
| Secondary | Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss) | Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 | Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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