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

Download Article


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

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

References:

1.      Appelbaum P, Grisso T, Frank E, O’Donnell S, Kupfer D. Competence of depressed patients for consent to research. Am J Psychiatry. 1999; 156: 1380-1384.

2.      Bosanac P, Castle D. Schizophrenia and depression. MJA Open. 2012; 1(4): 36-39.

3.      Bonnie R. Research with cognitively impaired subjects: unfinished business in the regulation of human research. Arch Gen Psychiatry. 1997;54:105–11.

4.      Candilis P, Geppert C, Fletcher K, Lidz C, Appelbaum P. Willingness of subjects with thought disorder to participate in research. Schiz Bull. 2006; 32 (1): 159-165.

5.      Carpenter W, Gold J, Lahti A. Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry. 2000; 57: 533-538.

6.      Cohen B, McGarvey E. Willingness and competence of depressed and schizophrenic inpatients to consent to research. J Am Acad Psychiatry Law. 2004; 32:134–43.

7.      Decision-Making Capacity. Available from: www.ucsf.edu/lm/ethics/Content%20Pages/fast_fact_competence.htm, accessed on March 27, 2015.

8.      Jeste D, Depp C, Palmer B. Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: an overview. Schiz Bull. 2006; 32 (1): 121-128.

9.      Kovnick J, Appelbaum P, Hoge S, Leadbetter R. Competence to consent to research among long-stay inpatients with chronic schizophrenia. Psych Serv. 2003; 54: 1247-52.

10.  McDermott B, Gerbasi J, Quanbeck C, Scott C. Capacity of forensic patients to consent to research: the use of the MacCAT-CR. J Am Acad Psychiatry Law. 2005; 33: 229-307.

11.  Moser D, Schultz S, Arndt S. Capacity to provide informed consent for participation in schizophrenia and HIV research. Am J Psychiatry. 2002; 159: 1201-1207.

12.  Palmer B, Dunn L, Appelbaum P. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry. 2005;62:726–733.

13.  Ray G. Psychopathology and psychiatric disorders in neuropsychiatric patients. A Prospective Study. Available from: http://www.priory.com/psych/neuropsy.htm, accessed on April 15, 2015.

14.  Siris S. Depression in schizophrenia: perspective in the era of “atypical” antipsychotic agents. Am J Psychiatry. 2000; 157: 1379-1389.

15.  Schizophrenia. NHS Choices. Available from: www.nhs.uk/Conditions/Schizophrenia/Pages/introduction.aspx, accessed on March 24, 2015.

16.  Stroup T, Appelbaum P, Hongbin G. Longitudinal consent-related abilities among research participants with schizophrenia: Results from the CATIE study. Schizophr Res. 2011; 130 (1-3): 47–52.

17.  Vogel-Scibilia S. The controversy over challenge and discontinuation studies: perspective from a consumer-psychiatrist. Biol Psychiatry. 1999;46:1021–114.

18.  Zisook S, McAdams L, Kuck J, Jude L, Jeste D. Depressive symptoms in schizophrenia. Am J Psychiatry. 1999;156(11):1736-43.