Trial Outcomes & Findings for Electroconvulsive Therapy in Clozapine Refractory Schizophrenia (NCT NCT00042224)

Last Updated: 2017-05-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

8 Weeks

Results posted on

2017-05-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	2 Medication Monotherapy Clozapine: Patients with psychotic symptoms will receive clozapine
Overall Study STARTED	20	19
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electroconvulsive Therapy With Medication n=20 Participants 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	Medication Monotherapy n=19 Participants Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.70 years STANDARD_DEVIATION 2.27 • n=5 Participants	42.78 years STANDARD_DEVIATION 1.82 • n=7 Participants	39.24 years STANDARD_DEVIATION 2.05 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Population: inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.

Outcome measures

Outcome measures
Measure	Electroconvulsive Therapy With Medication n=20 Participants 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	Medication Monotherapy n=19 Participants Drug: Clozapine Patients with psychotic symptoms will receive clozapine Other Names: • Clozaril
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.	50 Percentage of responders	0 Percentage of responders

Adverse Events

Electroconvulsive Therapy With Medication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medication Monotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Georgios Petrides, M.D.

Northshore LIJ Health System

Phone: 718-470-8569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place