Trial · NCT04105231
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Psychotic symptoms | 7 weeks follow-up | Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse. |
| Secondary | Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline) | 7 weeks follow-up | Timeline follow back method |
| Secondary | Cannabis use by self-reported days of cannabis use per week, since last study visit. | 7 weeks follow-up | Timeline follow back method |
| Secondary | Amount of cannabis use per day, self-reported, since last study visit. | 7 weeks follow-up | PSYSCAN cannabis questionnaire# 6-8 |
| Secondary | Response | 7 weeks follow-up | Response defined by PANSS total 25 percentile changes |
| Secondary | Remission | 7 weeks follow-up | Symptomatic remission is defined according to the Andreasen et al remission criteria. The criteria define symptomatic remission as a rating of no more than mild in four core positive and four core negative symptoms on the Positive and Negative Syndrome Scale (P1, P2 P3, N1, N4, N6, G5, G9,) that is sustained for ≥6 months. Because of the duration of this study, the requirement of 6 month will not be considered. |
| Secondary | Global illness severity | 7 weeks follow-up | Global illness severity is assessed with the Clinical Global Impression Scale (CGI). We will use the severity (CGI-S) at baseline and improvement (CGI-I) scores of the CGI at the following visits. Response will be defined as much improved or better on the CGI-I. The main item 'severity of illness' is measured on a 7-point Likert scale (from 1 'normal, not at all ill' to 7 'among the most extremely ill patients'). |
| Secondary | Psychosocial functioning | 7 weeks follow-up | Personal and Social Performance Scale (PSP). Higher is better, range 1-100. |
| Secondary | Neurocognitive functioning | 7 weeks follow-up | Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales. |
| Secondary | Subjective well-being | 7 weeks follow-up | Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life. |
| Secondary | Circadian rest-activity cycle | 7 weeks follow-up | Actigraphy. A wrist-worne device that measures kinetic energy. |
| Secondary | Subjective sleep quality | 7 weeks follow-up | Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales. |
| Secondary | Objective sleep evaluation | 7 weeks follow-up | Polysomnography (PSG). A measure of objective sleep variables |
| Secondary | Metabolomics | 7 weeks follow-up | Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood |
| Other | Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs) | From baseline to 2 weeks after end of treatment | Self-report |
| Other | Extrapyramidal and other side effects | 7 weeks follow-up | Udvalget for Kliniske Undersoegelser (UKU) short version A clinician-rated scale to assess antipsychotic side effects |
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.
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GET https://conductscience.org/api/trials/v1/NCT04105231/registered