Measuring Capacity to Consent to Research in Indian Schizophrenic Patients with Depressive Symptoms

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Authors : Melisa Pereira, Nilesh Shah, Avinash Desousa, Renita Bhamrah, Sridharan Kannan



Depressive symptoms are commonly observed in schizophrenia. Around one-fourth of patients with schizophrenia meet criteria for a depressive disorder at some point of time in their lives. Schizophrenia can lead to impaired decision-making capacity resulting from delusions, lack of insight, impaired memory and mental flexibility. Moreover, depression can negatively influence concentration and abstract reasoning abilities, and also can be linked to nihilism and a decreased concern for personal well-being. Evaluating decisional capacity involves determining whether or not a patient/subject is psychologically or legally competent of making adequate decisions about research activities. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) is a semi-structured interview format most extensively utilized by researchers for assessing the decision-making capacity of potential research subjects. Although the tool has expanded its global presence, little is known about its application in Indian schizophrenic patients with depressive symptoms. Therefore, the present study was designed to measure the decisional capacity to consent to research in Indian schizophrenic patients with depressive symptoms.


Hundred patients aged 18–65 years with DSM-IV-TR diagnoses of schizophrenia participated in this study. Of these, 50 patients had depressive symptoms as defined by a score of ≥ 7 on the Montgomery–Asberg Depression Rating Scale (MADRS). The patients were asked to pretend that they were potential candidates for a hypothetical trial involving an new antipsychotic drug, and their decisional capacity to consent to research was assessed using the MacCAT-CR.


The study results suggest that a majority of patients in both the schizophrenia and the schizophrenia with depressive symptoms groups demonstrated adequate understanding to consent to research. Schizophrenic patients with depressive symptoms showed weaker performance on all four abilities of decisional capacity in comparison to patients with schizophrenia, as measured by MacCAT-CR. This difference was statistically significant for ‘understanding’, ‘appreciation’ and ‘reasoning’ but not for ‘expression of choice’.


These preliminary findings are among the first to illustrate the decision-making capacity to consent to research in Indian schizophrenic patients with depressive symptoms. Future work calls for larger samples to provide valuable information in this area.


schizophrenia/depressive symptoms/decisional capacity/competence/consent


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