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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH060390 | U.S. NIH Grant/Contract | View source | |
| DSIR AT-SO | Other Identifier | NorthShore LIJ Health System |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 ECT plus clozapine | Experimental | Electroconvulsive therapy ECT plus clozapine for 8 weeks |
|
| 2 Clozapine | Active Comparator | Clozapine for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive Therapy (ECT) | Procedure | ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group. | Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which 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. | 8 Weeks |
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Inclusion criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Georgios Petrides, MD | New Jersey Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
In an 8-week random-assignment study incorporating nonblinded treatment and blinded assessments, patients with antipsychotic and clozapine-resistant schizophrenia were assigned to two treatment groups.
participants were recruited from the inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Electroconvulsive Therapy With Medication | Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. Clozapine: Patients with psychotic symptoms will receive clozapine |
| FG001 | 2 Medication Monotherapy | Clozapine: Patients with psychotic symptoms will receive clozapine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electroconvulsive Therapy With Medication | Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group. | Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which 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. | inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y. | Posted | Number | Percentage of responders | 8 Weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electroconvulsive Therapy With Medication | Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georgios Petrides, M.D. | Northshore LIJ Health System | 718-470-8569 | GPetride@NSHS.EDU |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004565 | Electroconvulsive Therapy |
| D003024 | Clozapine |
| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
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| Clozapine | Drug | Patients with psychotic symptoms will receive clozapine |
|
|
| BG001 |
| Medication Monotherapy |
Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Electroconvulsive Therapy With Medication | Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril |
| OG001 | Medication Monotherapy | Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Medication Monotherapy | Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril | 0 | 19 | 0 | 19 |
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| D011580 | Psychological Techniques |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |