Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwell Health
With
National Institute of Mental Health (NIMH)
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 one of the four psychotic items on the psychotic sub-scale or a score of 12 on these 4 items combined.
Clinical Global Impressions (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)
You may not be if
schizoaffective disorder; bipolar disorder;
current affective episode;
Electroconvulsive Therapy (ECT) within the past 6 months
history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition, behavior, 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 Hamilton Depression Rating Scale (HAM-D)
clinical determination that mood stabilizers were necessary and therefore could not be discontinued.
pregnancy.
affective disorders and prominent depressive symptoms because ECT is well known to be effective in those situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms.
