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Question:
My question is for Dr. Hsiao: The NIMH advertises clinical trials. The participants receive PET scans and neuropsych. testing as well as dealing with the best physicians in the treatment of mental illness.

Could you describe how you handle the placebos given to some participants? My daughter refuses to get this thorough workup for her brain disease because she is worried that if given a placebo, she will be psychotic during the drug trials. When they are over, she will be sicker than when she arrived.

As she is indigent, I would like for her to get the best psychiatric workup possible, as her diagnosis seems to drift between bipolar and schizophrenic.

E.L.C.
Granby, North Carolina


Answered by John Hsiao, M.D.:
Many NIMH-sponsored research studies do not involve placebos. You and your daughter may be interested in NIMH's Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project. If your daughter is over 18, she may be eligible for a randomized clinical trial comparing the new atypical antipsychotics with each other and with a conventional antipsychotic in people with schizophrenia. The trial involves randomized double-blind treatment, but no placebo. It is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia, and is designed for people with schizophrenia who may benefit from a medication change. All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate. There are 50 clinical sites spread across the United States, including several in North Carolina. For more information, including how to find the closest site, you and your daughter could go to: http://www.nimh.nih.gov/studies/2schpsydiscatie.cfm.

While the CATIE schizophrenia trial does not involve a placebo, your daughter's concern that she might become psychotic if placed on placebo treatment is very reasonable. If she is interested in participating in a study that involves either placebo treatment or discontinuing her antipsychotic medication, the study coordinator will warn her specifically about the risk of relapse and will tell her how the study will handle things to ensure her safety if she should relapse. This isn't just a matter of ethics on the part of researchers. It's the law, and it applies to all human research, not just federally-funded studies.

You should be aware that at this time PET scans are largely an experimental tool for studying metabolic abnormalities in neuropsychiatric and other disorders. The routine evaluation of schizophrenia or bipolar disorder does not require PET scanning. Neuropsychological testing is used for research, but also can be helpful in guiding rehabilitation for patients with these disorders.


John Hsiao, M.D.


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