Trial reportSchizophrenia research2011
Longitudinal consent-related abilities among research participants with schizophrenia: results from the CATIE study.
Trial report in Schizophrenia research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic review on the prevalence of lack of capacity in medical and psychiatric settings.Clinical medicine (London, England) · 2015Pooled it
- Ziprasidone versus other atypical antipsychotics for schizophrenia.The Cochrane database of systematic reviews · 2009Pooled it
- Consenting practices to enhance comprehension in research involving individuals with schizophrenia and bipolar affective disorder in Uganda: a qualitative inquiry.BMC psychology · 2026Article
- Increasing participation of people with thought disorder in clinical research.European psychiatry : the journal of the Association of European Psychiatrists · 2026Review
- Perspectives on Recruitment and Representativeness in Forensic Psychiatric Research.Frontiers in psychiatry · 2021Article
- Competence to Consent and Its Relationship With Cognitive Function in Patients With Schizophrenia.Frontiers in psychiatry · 2019Review
- A design and focus group evaluation of dietary choices tools for an underserved population.The mental health clinician · 2016Article
- Article
- Assessment of Capacity to Consent to Research Among Psychiatric Outpatients: Prevalence and Associated Factors.The Psychiatric quarterly · 2016Article
- Decision-making capacity for research participation among addicted people: a cross-sectional study.BMC medical ethics · 2016Article
- Functional mental capacity, treatment as usual and time: magnitude of change in secure hospital patients with major mental illness.BMC research notes · 2015Article
- Informed consent in the psychosis prodrome: ethical, procedural and cultural considerations.Philosophy, ethics, and humanities in medicine : PEHM · 2014Review
- Changes in capacity to consent over time in patients involved in psychiatric research.The British journal of psychiatry : the journal of mental science · 2013Article
- Participants with schizophrenia retain the information necessary for informed consent during clinical trials.The Journal of clinical psychiatry · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
objectiveResearch participants must have adequate consent-related abilities to provide informed consent at the time of study enrollment. We sought to determine if research participants with schizophrenia maintain adequate consent-related abilities during a longitudinal study. If participants lose abilities during a trial they may not be able to judge and protect their interests. If reduced abilities are common or can be predicted, special protections can be targeted appropriately.
methodWe examined longitudinal consent-related abilities of participants in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study using the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) at protocol-specified times over 18 months.
resultsOf 1158 research participants in this analysis, most (n=650, 56%) had a stable pattern of MacCAT-CR Understanding scores, 235 (20%) improved substantially with no evidence of decline, 273 (24%) had at least one assessment with substantial worsening. During the course of the trial, 43 (4%) fell below the initial threshold for adequate capacity, which was predicted by lower Understanding scores, more severe positive symptoms, and poorer neurocognitive functioning at baseline, and by increases in negative symptoms and deteriorating global status.
conclusionsMost participants in this long-term study had stable or improved consent-related abilities, but almost one-fourth experienced substantial worsening and 4% of participants fell below the study's capacity threshold for enrollment. Clinical investigators should monitor with special care individuals with marginal capacity or higher levels of psychotic symptoms at study entry and those who exhibit clinical worsening during a study.
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