Abstract:

BACKGROUND & OBJECTIVES

In clinical trials, the informed consent process intends to provide information to the individuals about the risks, rights, and benefits of participation. However, obtaining informed consent from subjects with diminished mental abilities and impaired capacity to consent has been a challenge for many researchers. In addition, little is known about the willingness of Indian schizophrenic patients with depressive symptoms to participate in psychiatry research. The present study was designed to understand the attitudes of Indian schizophrenic patients with depressive symptoms regarding clinical trial participation.

METHODS

This interview-based study was conducted on fifty patients aged 18–65 years who met the DSM-IV diagnostic criteria for schizophrenia, and who 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 antipsychotic drug, and were given the following three questions to express their attitudes towards clinical trial participation: 1). Is there a need for clinical trials in India? 2) As a study subject you will receive monetary reimbursement per visit. Do you feel you should be reimbursed? Why? 3) What is your level of convenience with respect to travel/stay at the hospital for clinical trial procedures? All of the fifty patients completed the interview-based study. Agree/disagree/do not know options were used to assess the attitude assessment sections.

RESULTS

Attitudes toward clinical research were positive. All (100 %) patients were of the opinion that clinical trials should be conducted in India. When asked about thoughts on monetary reimbursements per visit, twenty eight (56%) patients agreed to the fact that such reimbursement for research participation should be offered for their time off from work to attend study visits. The remaining twenty two (44 %) patients felt that their participation would be for societal benefits and for receiving an additional care for their concerned disease. Regarding convenience, all patients chose to travel once a week to the study site and 76% of them agreed to hospitalization for trial-related procedures.

CONCLUSION

The attitudes of Indian schizophrenic patients with depressive symptoms were indicative of their willingness to participate in psychiatry research. Conducting a study with a large sample using structured interviews should validate the results of this study.

KEYWORDS

schizophrenia; depression; patient attitudes; clinical trial; reimbursement

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