Trial · NCT03510325
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment efficacy rate | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | A 40% reduction or more of the total score in the Positive and Negative Syndrome Scale (PANSS). The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe). |
| Primary | All-cause dropout rate | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | Marked by the treatment discontinuation for any reasons, including poor efficacy, intolerance of adverse reactions, poor compliance and other reasons. |
| Secondary | Change from baseline in Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS) | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS). The CRDPS scale evaluates eight symptom dimensions of psychosis. Each symptom domain is rated for the past 7 days on a 5-point scale ranging from 0 (absent) to 4 (present and severe). |
| Secondary | Cost inventory | baseline,2 months,4 months, 6 months and 12 months | Direct medical costs (for example, antipsychotics costs, medical examinations costs, health care and service costs and adverse events costs) and indirect costs (such as traffic, nursing, and losing of labor) of the treatments. |
| Secondary | Change from baseline in Clinical Global Impression Scale-Severity (CGI-S) | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | Clinical Global Impression Scale-Severity (CGI-S), including assessment of disease severity and overall efficacy. The severity of the disease was scored on an eight-point scale ranging from 0 (not rated) to 7 (extremely severe). The overall efficacy was assessed on an 8-point scale ranging from 0 (not assessed) to 7 (significant deterioration). |
| Secondary | Change from baseline in Calgary Depression Scale for Schizophrenia (CDSS) | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | The Calgary Depression Scale for Schizophrenia (CDSS) consists of nine items, each scored from 0 to 3. A total score greater than 6 is considered depression. |
| Secondary | Social function | baseline,2 months,4 months and 6 months and 12 months | Chinese version of UPSA-B, the UCSD (University of California,San Diego) Performance-based Skills Assessment-Brief, consists of two parts: financial skill (A and B) and communication skill. The score of financial skill A range from 0 to 5. The score of financial skill B range from 0 to 6. The score of communication skill range from 0 to 9. The higher scores mean a better outcome. |
| Secondary | Life quality: The Heinirich Quality of life Scale (HRQOL) | baseline,2 months,4 months and 6 months and 12 months | The Heinirich Quality of life Scale (HRQOL) consists of 21 items, each scored from 0 to 6. The higher scores mean a better outcome. |
| Secondary | Life quality: Medication Satisfaction Questionnaire (MSN) | baseline,2 months,4 months and 6 months and 12 months | Medication Satisfaction Questionnaire (MSN) has one item, scored from 1 to 7. The higher scores indicate higher satisfaction with the medication. |
| Secondary | Life quality: Subjective Well-being under Neuroleptics (SWN) | baseline,2 months,4 months and 6 months and 12 months | Subjective Well-being under Neuroleptics (SWN) consists of 20 items, each scored from 1-6. |
| Secondary | Extrapyramidal adverse effects: The Barnes Akathisia Scale (BAS) | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | The Barnes Akathisia Scale (BAS) will be used to evaluate objective performance and subjective experience of akathisia, scored from 0 to 3, and the overall clinical evaluation of akathisia is scored from 0 to 5. The higher scores mean a more serious side effect. |
| Secondary | Extrapyramidal adverse effects: Simpson-Angus Extrapyramidal Side Effects Scale (SAS) | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | Simpson-Angus Extrapyramidal Side Effects Scale (SAS) consists of 10 items, each scored from 0 to 4. The higher scores mean a more serious side effect. |
| Secondary | Extrapyramidal adverse effects: Abnormal Involuntary Movement Scale (AIMS) | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | Abnormal Involuntary Movement Scale (AIMS) consists of 12 items. The first 10 of 12 items is scored from 0 to 4, and the last 2 is scored from 0 to 1. The higher scores mean the more obvious abnormal involuntary movement. |
| Secondary | Sexual dysfunction | baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months | Arizona Sexual Experiences Scale (ASEX) includes 5 items, each scored from 1-6. A total score greater than or equal to 19 and any item greater than or equal to 5, or any 3 items greater than or equal to 4, can help clinical diagnosis of sexual dysfunction. |
| Secondary | Change from baseline in cognitive function: MCCB | baseline,2 months,4 months and 6 months and 12 months | MATRICS consensus cognitive battery (MCCB) consists of 10 tests that assess cognitive performance in 7 domains, including processing speed, attention/vigilance, working memory, verbal memory, visual learning, reasoning and problem solving, and social cognition. |
| Secondary | Change from baseline in cognitive function: NBSC | baseline,2 months,4 months and 6 months and 12 months | New cognitive battery for patients with schizophrenia in China(NBSC). NBSC includes 4 tests from MCCB and 5 new tests (Trial making A, BACS, HVLT-R learning and recall, CPTIP, dominant hand Grooved Pegboard, Color Trails I and II, PASAT) |
| Secondary | Safety index: Blood pressure | baseline,2 months,4 months and 6 months and 12 months | Blood pressure in mmHg |
| Secondary | Safety index: Heart rate | baseline,2 months,4 months and 6 months and 12 months | Heart rate |
| Secondary | Safety index: Respiratory rate | baseline,2 months,4 months and 6 months and 12 months | respiratory rate |
| Secondary | Safety index: Vital signs | baseline,2 months,4 months and 6 months and 12 months | body temperature in celsius |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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
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