NCT00042224.

Trial name or title	Electroconvulsive therapy in clozapine refractory schizophrenia
Methods	Allocation: parallel, randomised Blind: single (outcome assessor) Country: USA Length of study: 8 weeks
Participants	Diagnosis: schizophrenia (DSM‐IV) Total N at randomisation = 39 Sex: both Age (years): range 18 to 60 Length of illness (years): range > 2 Inclusion criteria: diagnosis of schizophrenia according to DSM‐IV criteria duration of illness 2 years or greater resistance to at least 2 antipsychotics clozapine resistance capacity to give informed consent for women of childbearing capacity, a negative pregnancy test and patient agreement to use a medically accepted form of contraception Brief Psychiatric Rating Scale score of at least a 4 on 1 of the 4 psychotic items on the psychotic sub scale or a score of 12 on these 4 items combined CGI‐severity rating of at least moderate (score of 4) receiving at least two 400 mg doses of chlorpromazine equivalents for at least 4 weeks (may include newer antipsychotics) having substantial psychotic symptoms despite at least 12 weeks of treatment (at least 8 weeks at a consistent dose) Exclusion criteria: schizoaffective disorder bipolar disorder current affective episode ECT within the past 6 months history of epilepsy severe neurological or systemic disorder that could significantly affect cognition, behaviour, or mental status (other than tardive dyskinesia or neuroleptic‐induced parkinsonism) psychoactive substance dependence (other than nicotine or caffeine) within 1 month prior to entering the study a score of less than 18 on the 24‐item HAM‐D clinical determination that mood stabilisers were necessary and therefore could not be discontinued pregnancy affective disorders and prominent depressive symptoms because ECT is well‐known to be effective in such situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms
Interventions	ECT group: ECT plus clozapine for 8 weeks Control group: Clozapine for 8 weeks
Outcomes	Response rate*
Starting date	December 2000
Contact information	George Petrides, Northwell Health
Notes	No results have been published. *Response is defined as 40% reduction of symptoms in the psychotic symptom sub scale (hallucinatory behaviour, suspiciousness, conceptual disorganisation, and unusual thought content) of the BPRS at the end of the 8‐week study. BPRS assesses psychotic symptoms on an 18‐item scale. The severity of each item is rated on a continuous scale from 1 to 7, with 1 being the least severe and 7 being the most severe. Patients included in the study had at baseline at least a moderate score of 4 on 1 of the 4 psychotic items on the psychotic symptom sub scale or a score of 12 on all 4 of these items combined (ranges 4 to 28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub scale score that is 40% less than participants' baseline score. If a participant enters the study with a sub scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.