SchizophreniaPhase 1/2NCT00042224
Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
A Phase 1/2 study testing Electroconvulsive Therapy (ECT) and Clozapine in people with Schizophrenia, run by Northwell Health at 1 site in United States.
Trial summary
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Electroconvulsive Therapy (ECT) and Clozapine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Jul 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECT in Clozapine Refractory Schizophrenia
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
Read the detailed description
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
- Conditions
- Schizophrenia
- Being tested
- Electroconvulsive Therapy (ECT), Clozapine
- Keywords
- Electroconvulsive Therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive Therapy (ECT)Procedure or surgery
ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
ClozapineDrug
Also called Clozaril
Patients with psychotic symptoms will receive clozapine
| Study group | Role | What they receive |
|---|---|---|
| 1 ECT plus clozapine | Experimental | Electroconvulsive therapy ECT plus clozapine for 8 weeks Receives: Procedure: Electroconvulsive Therapy (ECT); Drug: Clozapine |
| 2 Clozapine | Active comparator | Clozapine for 8 weeks Receives: Drug: Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2002 (estimated)
- Study startDec 2000
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, George Petrides, Northwell Health
- Investigators
- Georgios Petrides, MD, Principal investigator, New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042224
- Sponsor's protocol ID
- R01MH060390
- Other IDs
- R01MH060390, DSIR AT-SO
- Status last verified
- Apr 2017
- First submitted
- 24 Jul 2002
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECT in Clozapine Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT00042224
- Acronym / sponsor ID
- R01MH060390
- Conditions
- Schizophrenia
- Keywords
- Electroconvulsive Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2000
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Jul 2002 (estimated)
- Results
- Posted 15 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.
Detailed description
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 ECT plus clozapine | Experimental | Procedure: Electroconvulsive Therapy (ECT), Drug: ClozapineElectroconvulsive therapy ECT plus clozapine for 8 weeks |
| 2 Clozapine | Active comparator | Drug: ClozapineClozapine for 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive Therapy (ECT)ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. | Procedure or surgery | 1 ECT plus clozapine |
| ClozapineAlso: ClozarilPatients with psychotic symptoms will receive clozapine | Drug | 1 ECT plus clozapine, 2 Clozapine |
Primary outcome
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
Time frame: 8 Weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Petrides, MD principal investigator
New Jersey Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Electroconvulsive Therapy (ECT) and Clozapine in people with Schizophrenia, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.