Trial · NCT07184619
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS). | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale \[PANSS\] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). |
| Primary | Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs). | From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up) | Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs). |
| Secondary | Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score. | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint on the Clinical Global Impression Severity of Illness (CGI-S) scale: a 7-point scale ranging from 1 (no symptoms) to 7 (very severe) to assess the severity of a subject's condition. |
| Secondary | Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12). | Week 12 | Efficacy measured by Clinical Global Impression of Change \[CGI-C\]: a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change". Patients with ratings of 1,2 or 3 are considered as 'improved'. |
| Secondary | Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS. | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: a 7-item subscale designed to assess positive symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). |
| Secondary | Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale. | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint on the PSP scale: a 100-point single-item rating scale subdivided into 10 equal intervals that designed to assess the routine social functioning of patients with psychiatric disorders. |
| Secondary | Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF). | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint on the total score of the Quality of Life Enjoyment and Satisfaction Questionnaire: a 16-item scale, each rated from 1 (very poor) to 5 (very good). |
| Other | Change from baseline to endpoint (Week 12) on the Negative Symptoms sub-scale score of the PANSS. | From Baseline to Week 12. | Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: this is a 7-item subscale that was designed to assess negative symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). |
| Other | Change from baseline to endpoint (Week 12) on the Calgary Depression Scale for Schizophrenia (CDSS). | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint on the CDSS: a 9-item, observer-rated, semi-structured, goal-directed interview, validated for diagnosing depression in patients with schizophrenia. Each item is scored between "Absent" (0) to "Severe" (3), based on operational criteria. |
| Other | Change from baseline to endpoint (Week 12) on the Global Assessment of Functioning (GAF) scale. | From Baseline to Week 12. | Efficacy measured by the mean change from baseline to endpoint on the GAF scale ranging from 0 (inadequate information) to 100 (superior functioning), and is divided into 10-point ranges of functioning. |
| Other | Change from baseline to endpoint (Week 12) on the Medication Satisfaction Questionnaire (MSQ). | From Baseline to Week 12 | Efficacy measured by the mean change from baseline to endpoint on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication ranging from "extremely dissatisfied" (1) to "extremely satisfied" (7). |
| Other | Change from baseline to endpoint (Week 12) on the Cognitive Test Battery. | From Baseline to Week 12 | Efficacy measured by the mean change from baseline on the scores of the Cognitive Test Battery. This includes: the Digit Symbol Substitution test, Trail Making Test (Parts A and B), d2 Test of Attention, and verbal fluency measures. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07184619/registered