Trial · NCT03043820
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 in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS) | Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapies on symptom severity. |
| Primary | Change in cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia | Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapies on cognitive functioning |
| Secondary | Personal and social performance measured with the Personal and Social Performance scale (PSP) | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapy on personal and social performance. |
| Secondary | Thought disorder severity as measured with the Thought And Language Disorder scale (TALD) | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapy on severity of thought disorder. |
| Secondary | Participant's Quality of Life as measured with the EQ-5D-5L | Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapy on quality of life. |
| Secondary | Comorbid depression as measured with Beck's Depression Inventory (BDI). | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapy on comorbid depression |
| Secondary | Use of health-recourses as measured with the iMTA-MCQ | Baseline, at 12 weeks (end of treatment) and 6 months follow-up | Effect of the study therapy on use of recourses. |
| Secondary | Use of non-health recourses as measured with the iMTA-PCQ | Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapy on use of recourses. |
| Secondary | Language production assessment by analyzing speech samples | Baseline and at 12 weeks of treatment (end of treatment) | Effect of the study therapy on free speech. |
| Secondary | Symptom severity as measured with the Brief Negative Symptom Scale (BNSS) | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | Effect of the study therapies on symptom severity. |
| Other | Hormonal biomarkers for predicting treatment response to raloxifene | Baseline and at 12 weeks of treatment | Hormonal biomarkers (in women: prolactin, follicle stimulating hormone and 17-beta estradiol; in men: prolactin, 17-beta estradiol, testosterone and sex hormone binding globulin and c-reactive protein will be assessed in blood samples to examine whether these parameters predict treatment response to raloxifene augmentation. |
| Other | Deoxyribonucleic acid analysis for predicting treatment response to raloxifene | Baseline and at 12 weeks of treatment | Single nucleotide polymorphism (SNP) analysis of estrogen receptor gene 1 (ESR1) SNP rs2234693, rs9340799, rs2144025 and UGT1A8 gene rs1042597. |
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
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GET https://conductscience.org/api/trials/v1/NCT03043820/registered