Trial · NCT04478838
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded" | 0 and 52 weeks | Change in the Brief Psychiatric Rating Scale - total scores from baseline to 52 weeks. The score values for each item on the BPRS range from 1 to 7. The higher the score for each item the worse the outcome. The values for each item on the BPRS are scored as follows: 1- Not Present, 2 - Very Mild, 3- Mild, 4- Moderate, 5 - Moderately Severe, 6- Severe, 7- Very Severe. |
| Secondary | Exploratory Outcomes - Symptoms 1 using "The Clinical Global Impression - Schizophrenia Scale" | 0 and 52 weeks | Change in Clinical Global Impression - Schizophrenia (CGI-SCH) severity of illness scores from baseline to 52 weeks. The severity of illness score values for each item on the CGI- SCH range from 1 to 7. The higher the score for each item the worse the outcome. The severity of illness values are scored as follows: 1- Normal, not ill, 2 -Minimally ill, 3- Mildly ill, 4- Moderately ill, 5 - Markedly ill, 6- Severely ill, 7- Among the most severely ill. |
| Secondary | Exploratory Outcomes - Symptoms/Side Effects using "The Clinical Global Impression - Schizophrenia Scale" | 0 and 52 weeks | Change in Clinical Global Impression - Schizophrenia Scale (CGI-SCH) degree of change scores from baseline to 52. The values range from 1-7. The higher the score for each item the worse the outcome. The score value of each item are as follows: 1 - Very much improved, 2 - Much Improved, 3 - Minimally improved, 4 - No Change, 5 - Minimally Worse, 6- Much Worse, 7 - Very Much Worse |
| Secondary | Exploratory Outcomes - Symptoms 3 using the "Calgary Depression Scale for Schizophrenia" | 0 and 52 weeks | Change in Calgary Depression Scale (CDS) scores from baseline to 52 weeks. Scores range from 0-3 as follows: 0- Absent, 1- Mild, 2- Moderate, 3 - Severe. The higher the score for each item, the worse the outcome. |
| Secondary | Exploratory Outcomes - Symptoms 4 using the "Yale-Brown Obsessive-Compulsive Scale" | 0 and 52 weeks | Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores from baseline to 52 weeks. Scores range from 0-4 with higher scores indicating worsening of outcome. |
| Secondary | Exploratory Outcomes - Symptoms 5 using the "Hamilton Anxiety Scale" | 0 and 52 weeks | Change in Hamilton Anxiety Scale (HAM-A) scores from baseline to 52 weeks. Scores on each item range from 0-4 as follows: 0- not present, 1- mild, 2 - moderate, 3- severe, 4 - very severe. Higher scores on each item and total score indicate worsening of anxiety outcome. |
| Secondary | Exploratory Outcomes - Side Effects 1 using the "Leibowitz Social Anxiety Scale" | 0 and 52 weeks | Change in Liebowitz Social Anxiety Scale (LSAS) scores from baseline to 52 weeks. For each item, there are 2 scores; 1) score for fear of anxiety and 2) score for avoidance. For the fear of anxiety component of the scale, score ranges from 0-3 as follows: 0- None, 1- Mild, 2- Moderate, 3 - Severe. The scores for the Avoidance component of the scale ranges from 0-3 as follows: 0 - Never, 1- Occasionally, 2 - Often, 3 - Usually. The higher the score the worse the outcome. |
| Secondary | Exploratory Outcomes - Side Effects 2 using the "Neurological Evaluation Scale" | 0 and 52 weeks | Change in Neurological Evaluation Scale (NES) scores from baseline to 52 weeks. There are 12 items and scores for each item range from 0-2 with higher scores indicating worsening of outcome. Item 5 does not require a score. |
| Secondary | Exploratory Outcomes - Side Effects 3 using the "Glasgow Assessment Side-Effect Scale" | 0 and 52 weeks | Change in Glasgow Assessment Side-Effect Scale (GASS) scores from baseline to 52 weeks. Scores range from 0-3 as follows: 0 -Never, 1- Once, 2 - A few times, 3 - Everyday. The higher the score for each item and higher total indicates a worse side effect outcome. |
| Secondary | Exploratory Outcomes - Side Effects 4 using the "Drug Attitude Inventory" Scale | 0 and 52 weeks | Change in Drug Attitude Inventory (DAI) scores from baseline to 52 weeks. Scores are based on 30 true/false statements.There are 15 items that a patient who is fully adherent to their prescribed medication (and so would be expected to have a positive response to medication would answer true and 15 items such a patient would answer as false. Each positive answer is given a score of plus one, and each negative answer is given a score of minus one. The total positive score would indicate a positive response (adherent to medication) whereas a negative total score would indicate a negative response (non adherent to medication). |
| Secondary | Exploratory Outcomes - Side Effects 5 using the "Barnes Akathisia Rating Scale" | 0 and 52 weeks | Change in Barnes Akathisia Rating Scale (BARS) scores from baseline to 52 weeks. The total score for the global clinical assessment of akathisia ranges from 0-5 with higher score indicating a worsening of akathisia. |
| Secondary | Exploratory Outcomes - Side Effects 6 using the "Simpson Angus Scale" | 0 and 52 weeks | Change in Simpson Angus Scale (SAS) scores from baseline to 52 weeks. There are 13 items in the scale; scores on each item range from 0-4 with higher scores indicating worse extrapyramidal outcome. |
| Secondary | Exploratory Outcomes - Side Effects 7 using the "Abnormal Involuntary Movement Scale" | 0 and 52 weeks | Change in Abnormal Involuntary Movement Scale (AIMS) scores from baseline to 52 weeks. There are 13 items in the scale, scores on each item range from 0-4 with higher scores indicating a worse outcome in abnormal movements. |
| Secondary | Exploratory Outcomes - Wellbeing using the "Quality of Life and Satisfaction Questionnaire" | 0 and 52 weeks | Change in Quality of Life Scale (QLS) scores from baseline to 52 weeks. The scores for each item range from 0-6. The higher the score, the better the outcome. On several items, there is an additional score of "9" to indicate "not applicable". |
| Secondary | Exploratory Outcomes - Wellbeing 2 using the "Quality of Life and Satisfaction Questionnaire - Short Form" | 0 and 52 weeks | Change in Quality of Life and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) scores from baseline to 52 weeks. Scores range from 0-6 with lower scores indicating a worse outcome. |
| Secondary | Exploratory Outcomes - Wellbeing 3 using the "Subject Happiness Scale" | 0 and 52 weeks | .Change in Subjective Happiness Scale (SHS) scores from baseline to 52 weeks. There are 4 items; scores on each item range from 1-7 with higher scores indicating a happier outcome. |
| Secondary | Exploratory Outcomes - Function 1 using the "Social and Occupational Function Assessment Scale" | 0 and 52 weeks | Change in : Social and Occupational Function Assessment Scale (SOFAS). scores from baseline to 52 weeks. A total score ranges from 0-100 with higher scores indicating better social and occupational functioning.. |
| Secondary | Exploratory Outcomes - Function 2 using the "Personal and Social Performance Scale" | 0 and 52 weeks | Change in Personal and Social Performance scale (PSP) scores from baseline to 52 weeks. The ratings are based on four areas (a) socially useful activities, including work and study; b) personal and social relationships; c) self, and d) disturbing and aggressive behaviours. Overall score range from 1-100. The higher the overall rating, the better the outcome. The breakdown of the total Rating score are as follows: scores ranging from 1-30 reflect functioning so poor that intensive support or supervision is needed; ratings from 31-70 reflect manifest disabilities of various degrees; ratings from 71-100 reflect only mild difficulties. |
| Secondary | Exploratory Outcomes - Function 3 using the "Recovery Assessment Scale" | 0 and 52 weeks | Change in Recovery Assessment Scale (RAS) scores from baseline to 52 weeks. There are 41 items with scores on each item ranging from 1-5 with higher scores indicating better outcomes. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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GET https://conductscience.org/api/trials/v1/NCT04478838/registered