Trial · NCT07084831
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in cognitive performance after 24 weeks of treatment, relative to baseline. | 24 weeks | The within-participant change in the Brief Assessment of Cognition in Schizophrenia composite cognitive score from baseline to follow-up after 24 weeks. Higher score means better cognition. There is no max score, as the tests have different scoring methods (number correct, reaction time). |
| Secondary | Change in negative symptoms after 24 weeks of treatment, relative to baseline. | 24 weeks | The within-participant change in the Positive And Negative Syndrome Scale (PANSS) negative subscale from baseline to follow-up after 24 weeks. A higher score means more schizophrenia-related symptoms. The maximum score is 49. |
| Other | Change in Functional Skills assessment and training (FUNSAT) scores for ATM banking, ticket kiosk, and medication management after 12, 24 and 52 weeks of treatment, relative to baseline. | 12, 24 and 52 weeks | The within-participant change in the Functional Skills assessment and training (FUNSAT) scores for ATM banking, ticket kiosk and medication management from baseline to follow-up after 12, 24 and 52 weeks. Higher reaction time scores means worse functioning (without maximum), higher number correct means better functioning |
| Other | Change in Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) between baseline and week 24 | 24 weeks | The within-participant change in Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) between baseline and week 24. A higher score means better subjective and social cognition. |
| Other | Change in Subjective Scale to Investigate Social Cognition Scale scores (MRMET) between baseline and week 24 | 24 weeks | The within-participant change in Social Cognition Scale scores (MRMET) between baseline and week 24. A higher score means better subjective and social cognition. |
| Other | Change in Brief Assessment of Cognition in Schizophrenia (BACS) scores between baseline to week 12 and week 52. | Week 12 and 52 | The within-participant change in Brief Assessment of Cognition in Schizophrenia (BACS) scores between baseline to week 12 and week 52. Higher score means better cognition.There is no max score, as the tests have different scoring methods (number correct, reaction time). |
| Other | Change in the Positive And Negative Syndrome Scale (PANSS) Negative Subscale Factor from baseline to week 12 and week 52 | Week 12 and 52 | Within-participant change in the Positive And Negative Syndrome Scale (PANSS) Negative Subscale Factor from baseline to week 12 and week 52. A higher score means more schizophrenia-related symptoms. The maximum score is 49. |
| Other | Change in the Brief Negative Symptom Scale (BNSS) and Self-report of Negative Symptoms (SNS) scores from baseline to week 24 and week 52. | week 24 and 52 | Within-participant change in the Brief Negative Symptom Scale (BNSS) and Self-report of Negative Symptoms (SNS) scores from baseline to week 24 and week 52. A higher score on BNSS means more negative symptoms. The maximum score is 78. A higher score on SNS means more negative symptoms. The maximum score is 40. |
| Other | Change in the Positive And Negative Syndrome Scale (PANSS) Total and Positive Subscale scores from baseline to week 12; week 24 and week 52. | Week 12, 24 and 52 | Within-participant change in the Positive And Negative Syndrome Scale (PANSS)Total and Positive Subscale scores from baseline to week 12; week 24 and week 52. A higher score means more schizophrenia-related symptoms. The PANSS total score has a maximum of 210, while the positive scale has a maximum of 49. |
| Other | Change in safety assessments from baseline to week 4; week 12; week 24 and week 52 | week 4, 12, 24 and 52 | Within-participant change in safety assessments from baseline to week 4; week 12; week 24 and week 52. This is defined as the occurence of AEs during the study. The is no minimum or maximum. |
| Other | Change in the physical examination (blood pressure (systolic/diastolic)) | week 12, 24 and 52 | Within-participant change in the physical examination in the blood pressure (systolic/diastolic)) from baseline to week 12; week 24 and week 52. |
| Other | Change in the physical examination (heart rate) | week 12, 24 and 52 | Within-participant change in the physical examination in the heart rate from baseline to week 12; week 24 and week 52. |
| Other | Change in the physical examination( weight) | week 12, 24 and 52 | Within-participant change in the physical examination in the weight from baseline to week 12; week 24 and week 52. |
| Other | Change in the physical examination (examination organ systems) | week 12, 24 and 52 | Within-participant change in the physical examination in the examination organ systems from baseline to week 12; week 24 and week 52. |
| Other | Change in the physical examination(blood pressure, heart, rate, weight, examination organ systems) | week 12, 24 and 52 | Within-participant change in the physical examination (blood pressure, heart, rate, weight, examination organ systems) from baseline to week 12; week 24 and week 52. |
| Other | Change in the Simpson Angus Scale (SAS) from baseline to week 12; week 24 and week 52. | week 12, 24 and 52 | Within-participant change in the Simpson Angus Scale (SAS) from baseline to week 12; week 24 and week 52. Higher scores on the SAS (max 40), means that the participants has more adverse events |
| Other | Change in the Barnes Akathisia Rating Scale (BARS) from baseline to week 12; week 24 and week 52. | week 12, 24 and 52 | Within-participant change in the Barnes Akathisia Rating Scale (BARS) from baseline to week 12; week 24 and week 52. Higher scores on the BARS (max 14) mean more adverse events. |
| Other | Change in the UKU Side Effect Rating Scale from baseline to week 12; week 24 and week 52. | week 12, 24 and 52 | Within-participant change in the UKU Side Effect Rating Scale from baseline to week 12; week 24 and week 52. Higher scores on the UKU (max 144) mean more adverse events. |
| Other | Change in the ASSIST from baseline to week 12; week 24 and week 52. | week 12, 24 and 52 | Within-participant change in the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) from baseline to week 12; week 24 and week 52. H More items ticked on the ASSIST means that the participants has more addictions. |
| Other | Incidence of treatment emergent adverse events (TEAE) defined as incidence of AEs observed from started of treatment initiation until the end of safety follow-up visit. | Week 4, 12, 24, 52 | Incidence of treatment emergent adverse events (TEAE) defined as incidence of AEs observed from started of treatment initiation until the end of safety follow-up visit, will also be summarized by system organ class and preferred term (MedDRA). Serious TEAEs and TEAEs leading to study treatment discontinuation will also be summarized by system organ class and preferred term.. |
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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