Trial · NCT01779700
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | QTcB Change | Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112 | To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value. |
| Primary | Levels of Lymphocyte | Baseline, 4 weeks, 8 weeks | To determine the safety of fingolimod, as measured by the absolute lymphocyte count |
| Primary | Symptom Changes - PANSS Total Score | Baseline, 4 weeks, 8 weeks | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. |
| Secondary | Verbal Memory - BACS | Baseline, 4 weeks, 8 weeks | The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition. The BACS utilizes 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic\&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. |
| Secondary | Cognition Change - BACS | Baseline, 4 weeks, 8 weeks | The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic\&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. |
| Secondary | Cognition Change - Trails B | Baseline, 4 weeks, 8 weeks | The Trail Making Test-Part B (Trails B) is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric. The score is the number of seconds it took to complete the test. |
| Secondary | Positive Symptom Change - PANSS | Baseline, 4 weeks, 8 weeks | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. |
| Secondary | Negative Symptom Change - PANSS | Baseline, 4 weeks, 8 weeks | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. |
| Secondary | Plasma Cytokines Levels - IL-10 | Baseline, 4 weeks, 8 weeks | To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IL-17A | Baseline, 4 weeks, 8 weeks | To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IL-1BETA | Baseline, 4 weeks, 8 weeks | To assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IL-2 | Baseline, 4 weeks, 8 weeks | To assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IL-4 | Baseline, 4 weeks, 8 weeks | To assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IL-6 | Baseline, 4 weeks, 8 weeks | To assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IL-8 | Baseline, 4 weeks, 8 weeks | To assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - TNFa | Baseline, 4 weeks, 8 weeks | To assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo |
| Secondary | Plasma Cytokines Levels - IFNgamma | Baseline, 4 weeks, 8 weeks | To assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo |
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/NCT01779700/registered