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.
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.
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.
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
schizophrenia; depression; patient
attitudes; clinical trial; reimbursement
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