The use of the stabilization period in electroconvulsive therapy research in schizophrenia: II. Implementation.

ABSTRACT

BACKGROUND: Electroconvulsive therapy (ECT) has been used to treat schizophrenia since its inception in 1938. Nonetheless, there has never been a research study documenting the efficacy of ECT in schizophrenia. All ECT studies suffered unexceptable methodological flaws. The authors hypothesized the 3-week stabilization period as 1) a screening method for ECT responders, 2) a procedure for obtaining a homogeneous group of patients ideally suitable for the continuation treatment study, and, 3) as a part of our relapse criteria. METHOD: One hundred and fourteen schizophrenic patients received acute Phase I treatment with bilateral ECT and flupenthixol (12-24 mg/d). After the first sign of clinical improvement, all patients had to pass a 3-week stabilization period during which their clinical improvement had to be sustained. The patients had to receive at least 20 ECT treatments before being considered unresponsive to ECT. Fifty one patients enrolled in the continuation (Phase II) treatment study, and were randomized to the 3 treatment groups. RESULTS: In Phase I study, 58 patients were ECT responders by our criteria, 43 were nonresponders, and 13 were drop-outs. Forty five patients either relapsed or completed the Phase II study, while 6 patients dropped out. By our relapse criteria, 6 of 15 relapsed in the combined C-ECT and flupenthixol group, and 14 of 15 relapsed in both the group treated with C-ECT alone or flupenthixol alone. The use of the stabilization period in this study could complete all three objectives previously described. CONCLUSIONS: The use of the stabilization period is very useful in ECT research in schizophrenia.