Status:
WITHDRAWN
Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia Patients
Lead Sponsor:
Geha Mental Health Center
Conditions:
Schizophrenia
Treatment Resistant Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background: schizophrenia is a debilitating mental disorder affecting about 1% of the general population. About 30% of patients will not react to current drug treatment and defined as treatment-resist...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of schizophrenia according to DSM-IV-TR criteria
- Treatment-resistant schizophrenia, defined as: documented treatment failure (insufficient clinical response or severe adverse effects) of two antipsychotics (one of them should be atypical) for an adequate duration of 6 weeks and in a sufficient dose of at least 600 mg/day of chlorpromazine equivalent
- Age 18-65 years
- Basal PANSS \> 75
- CGI-S \>3
- Persistent positive psychotic symptoms, with rating scores of moderate or worse on at least two of four positive symptom items (delusions, conceptual disorganization, hallucinatory behavior, and suspiciousness/persecution) on Positive and Negative Syndrome Scale (PANSS).
- Competent and willing to provide written, informed consent
Exclusion
- Patients with concomitant treatment with lithium, anticonvulsants, antidepressants
- Patients with underlying severe medical illness, such as cardiovascular disease, cerebrovascular disease, bone marrow suppression or epilepsy
- A previous trial of clozapine or amisulpride
- Any known contraindication for treatment with clozapine or amisulpride
- Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01448499
Start Date
October 1 2011
Last Update
December 9 2015
Active Locations (1)
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1
Geha Mental Health Center
Petah Tikva, Israel, 49000