Measuring Capacity to Consent to Research in Indian Schizophrenic Patients with Depressive Symptoms
Abstract:
BACKGROUND
& OBJECTIVES
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.
METHODS
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.
RESULTS
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’.
CONCLUSION
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.
KEY WORDS
schizophrenia/depressive
symptoms/decisional capacity/competence/consent
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