SchizophreniaPhase 3NCT00189995
Clozapine IM and Aggression in Schizophrenic Patients
A Phase 3 study testing clozapine and haloperidol in people with Schizophrenia, run by Beersheva Mental Health Center at 2 sites in Israel.
Trial summary
Aggressive, persistent aggression and impulsive behavior are frequently observed in schizophrenic patients. According to some researchers "more than 50% of all psychiatric patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening behavior and agitation to assault"(1). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- clozapine and haloperidol
- How many people
- 0 participants
- Where
- 2 sitesIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenic, schizoaffective, or schizophreniform according to DSM-IV
- treatment-resistant
- presenting pathologic violent-aggressive behavior on admission
- at risk for self damage
- age: 18-65
- patient is not participating in any other study at time of this study
Show all 9Show fewer
- minimal score of 70 on PANSS
- prior resistance to at least 2 different classes of neuroleptics
- OAS scores of at least 4 points in physical aggression sections and at least 2 points in verbal aggression section
Who cannot join
- neutropenia or any other abnormal CBC result
- myeloproliferative disease
- chronic physical diseases such as liver, renal or cardiac diseases
- history of alcohol or drug abuse
- history of drug induced granulocytopenia/agranulocytosis
- alcoholic/drug psychosis or intoxication
Show all 10Show fewer
- carbamazepine or other bone marrow suppressor treatment
- uncontrolled epilepsy
- paralytic ileus
- hypersensitivity to clozapine
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Beersheva Mental Health Center
Beersheva
Nes Ziona Medical Center
Ness Ziona
About this study
Official title: Intramuscular Clozapine in the Management of Aggression in Schizophrenic Patients
Aggressive, persistent aggression and impulsive behavior are frequently observed in schizophrenic patients. According to some researchers "more than 50% of all psychiatric patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening behavior and agitation to assault"(1). It is a common cause of psychiatric admission and is a therapeutic issue. The treatment of these symptoms is a clinical problem for both patients and staff. Violent behavior, a major detrimental factor in stigmatization of the mentally ill, also poses physical danger for the patients themselves. Current pharmacotherapy of pathologic aggression involves the use of multiple agents (typical and atypical antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones, and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of response (2-6). Unfortunately, these approaches lead to numerous side effects. Poor or noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation. Currently, typical neuroleptics are still the first choice in treating acute aggressive symptoms, while risperidone and olanzapine could be alternatives (5-7). Typical depot neuroleptics should be considered in cases where medication compliance is a problem. Most clinical information on treating of aggression has been collected about atypical neuroleptics, particularly regarding clozapine.
Clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients. According to the FDA - it is the drug of choice in suicidal and aggressive patients, due-to psychotic state. It was found helpful in nearly 30% of resistant schizophrenic patients. Concerning the parenteral administration of clozapine - very little data is available today.
This study aims to investigate efficacy and safety (psychopathology, and side effects) of parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a double-blind trial.
- Conditions
- Schizophrenia
- Being tested
- clozapine, haloperidol
- Keywords
- schizophrenia, aggression, clozapine, efficacy, double-blind
- Medical subject headings
- Schizophrenia, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clozapineDrug
haloperidolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
Overt Aggression Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vladimir Lerner, Beersheva Mental Health Center
- Investigators
- Valdimir Lerner, MD, PhD, Principal investigator, Ben-Gurion University of the NegevBaruch Spivak, MD, Principal investigator, Tel Aviv UniversityChanoch Midownik, MD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189995
- Sponsor's protocol ID
- BMHC-4000
- Status last verified
- Oct 2005
- First submitted
- 11 Sep 2005
- Last updated
- 24 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Clozapine in the Management of Aggression in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00189995
- Acronym / sponsor ID
- BMHC-4000
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, aggression, clozapine, efficacy, double-blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aggressive, persistent aggression and impulsive behavior are frequently observed in schizophrenic patients. According to some researchers "more than 50% of all psychiatric patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening behavior and agitation to assault"(1). It is a common cause of psychiatric admission and is a therapeutic issue. The treatment of these symptoms is a clinical problem for both patients and staff. Violent behavior, a major detrimental factor in stigmatization of the mentally ill, also poses physical danger for the patients themselves. Current pharmacotherapy of pathologic aggression involves the use of multiple agents (typical and atypical antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones, and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of response (2-6). Unfortunately, these approaches lead to numerous side effects. Poor or noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation. Currently, typical neuroleptics are still the first choice in treating acute aggressive symptoms, while risperidone and olanzapine could be alternatives (5-7). Typical depot neuroleptics should be considered in cases where medication compliance is a problem. Most clinical information on treating of aggression has been collected about atypical neuroleptics, particularly regarding clozapine.
Clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients. According to the FDA - it is the drug of choice in suicidal and aggressive patients, due-to psychotic state. It was found helpful in nearly 30% of resistant schizophrenic patients. Concerning the parenteral administration of clozapine - very little data is available today.
This study aims to investigate efficacy and safety (psychopathology, and side effects) of parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a double-blind trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- schizophrenic, schizoaffective, or schizophreniform according to DSM-IV
- treatment-resistant
- presenting pathologic violent-aggressive behavior on admission
- at risk for self damage
- age: 18-65
Key exclusion criteria (10 listed)
- neutropenia or any other abnormal CBC result
- myeloproliferative disease
- chronic physical diseases such as liver, renal or cardiac diseases
- history of alcohol or drug abuse
- history of drug induced granulocytopenia/agranulocytosis
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 |
|---|---|---|
| clozapine | Drug | – |
| haloperidol | Drug | – |
Primary outcome
Positive and Negative Syndrome Scale
Overt Aggression Scale
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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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.
Valdimir Lerner, MD, PhD principal investigator
Ben-Gurion University of the Negev
Baruch Spivak, MD principal investigator
Tel Aviv University
Chanoch Midownik, MD principal investigator
Ben-Gurion University of the Negev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clozapine and haloperidol in people with Schizophrenia, run by Beersheva Mental Health Center at 2 sites in Israel.
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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Positive and Negative Syndrome Scale. The study lists 2 primary outcomes in all. 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 24 Jul 2013.