SchizophreniaClozAmiNCT01448499
Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia Patients
A study testing Clozapine, Amisulpride and Clozapine+Amisulpride in people with Schizophrenia and Treatment Resistant Disorders, run by Geha Mental Health Center at 1 site in Israel.
Trial 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-resistant schizophrenia patients (TRSP). The best studied therapeutic option for this population is clozapine therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Treatment Resistant Disorders
- What is being tested?
- Clozapine, Amisulpride and Clozapine+Amisulpride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clozapine Versus Amisulpride Versus Their Combination in the Treatment of Drug-resistant Schizophrenia Patients
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-resistant schizophrenia patients (TRSP). The best studied therapeutic option for this population is clozapine therapy. Clozapine was shown to be effective than any other antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not demonstrated to be more effective than clozapine monotherapy. Albeit Clozapine superiority in TRSP, its use may be involved with many adverse effects, some of them are life-threatening, and need for routine blood tests. Amisulpride is an atypical antipsychotic drug with a different mechanism of action than clozapine, with less adverse effects. No study compared directly amisulpride and clozapine in TRSP.
Study objective: to compare, for the first time, the broad clinical effectiveness of clozapine and amisulpride and their combination in TRSP.
Read more
Study Design: a clinical, prospective, naturalistic, randomized, comparative study simulating a real-world approach of clinical decision making.
Methods: a total of 140 TRSP will be recruited from a large regional mental health center. Participants will be randomized into two treatment groups (70 in each group): clozapine monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks of treatment. In case of treatment failure (insufficient clinical response or severe adverse effect) participants will be offered either to switch to clozapine treatment (for failed amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment will be made using clinician rated scales and self-completed questionnaires, rating the broad phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive, cognitive and quality of life) and drug-related adverse effects (objective and subjective).
Analysis: comparison of the effectiveness of the three treatment groups: amisulpride, clozapine and their combination, in the various dimensions of TRSP.
- Conditions
- Schizophrenia, Treatment Resistant Disorders
- Being tested
- Clozapine, Amisulpride, Clozapine+Amisulpride
- Keywords
- schizophrenia, clozapine, amisulpride, combination, treatment resistant
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
escalating dose of clozapine up to 900 mg/day
AmisulprideDrug
escalating dose of amisulpride up to 800 mg/day
Clozapine+AmisulprideDrug
augmentation of clozapine with amisulpride
| Study group | Role | What they receive |
|---|---|---|
| Clozapine | Experimental | Clozapine monotherapy Receives: Drug: Clozapine |
| Amisulpride | Experimental | Amisulpride monotherapy Receives: Drug: Amisulpride |
| Augmentation | Experimental | Augmentation of clozapine with amisulpride Receives: Drug: Clozapine+Amisulpride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
Measured: 10, 20 weeks and endpoint
Secondary outcomes (6)
Change from baseline in Clinical Global Impression - Severity (CGI-S)
Measured: 10 , 20 weeks and endpoint
Change from baseline in Beck Depression Inventory (BDI)
Measured: 10 , 20 weeks and endpoint
Change from baseline in Beck Anxiety Inventory (BAI)
Measured: 10, 20 weeks and endpoint
Change from baseline in Schizophrenia Quality of Life Scale (SQLS)
Measured: 10, 20 weeks and endpoint
Change from baseline in Simpson-Angus Scale (SAS)
Measured: 5, 10, 15, 20 weeks, endpoint
Change from baseline in Clozapine Adverse Effects Inventory (CAEI)
Measured: 5, 10 ,15, 20 weeks, endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geha Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Krivoy, Geha Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448499
- Sponsor's protocol ID
- GMCH-014-11
- Acronym
- ClozAmi
- Status last verified
- Dec 2015
- First submitted
- 2 Oct 2011
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clozapine Versus Amisulpride Versus Their Combination in the Treatment of Drug-resistant Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT01448499
- Acronym / sponsor ID
- ClozAmi / GMCH-014-11
- Conditions
- Schizophrenia, Treatment Resistant Disorders
- Keywords
- schizophrenia, clozapine, amisulpride, combination, treatment resistant
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geha Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- First posted
- 7 Oct 2011 (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.
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-resistant schizophrenia patients (TRSP). The best studied therapeutic option for this population is clozapine therapy. Clozapine was shown to be effective than any other antipsychotic drug in TRSP. Moreover, augmentation of clozapine was not demonstrated to be more effective than clozapine monotherapy. Albeit Clozapine superiority in TRSP, its use may be involved with many adverse effects, some of them are life-threatening, and need for routine blood tests. Amisulpride is an atypical antipsychotic drug with a different mechanism of action than clozapine, with less adverse effects. No study compared directly amisulpride and clozapine in TRSP.
Study objective: to compare, for the first time, the broad clinical effectiveness of clozapine and amisulpride and their combination in TRSP.
Study Design: a clinical, prospective, naturalistic, randomized, comparative study simulating a real-world approach of clinical decision making.
Methods: a total of 140 TRSP will be recruited from a large regional mental health center. Participants will be randomized into two treatment groups (70 in each group): clozapine monotherapy and amisulpride monotherapy. Assessment will be done following 10 and 20 weeks of treatment. In case of treatment failure (insufficient clinical response or severe adverse effect) participants will be offered either to switch to clozapine treatment (for failed amisulpride treatment) or to augment clozapine with amisulpride (for failed clozapine monotherapy patients). Thereafter, participants will be followed-up for a year. Assessment will be made using clinician rated scales and self-completed questionnaires, rating the broad phenomenology of schizophrenia (psychosis, mood, anxiety, obsessive-compulsive, cognitive and quality of life) and drug-related adverse effects (objective and subjective).
Analysis: comparison of the effectiveness of the three treatment groups: amisulpride, clozapine and their combination, in the various dimensions of TRSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clozapine | Experimental | Drug: ClozapineClozapine monotherapy |
| Amisulpride | Experimental | Drug: AmisulprideAmisulpride monotherapy |
| Augmentation | Experimental | Drug: Clozapine+AmisulprideAugmentation of clozapine with amisulpride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Clozapineescalating dose of clozapine up to 900 mg/day | Drug | Clozapine |
| Amisulprideescalating dose of amisulpride up to 800 mg/day | Drug | Amisulpride |
| Clozapine+Amisulprideaugmentation of clozapine with amisulpride | Drug | Augmentation |
Primary outcome
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
Time frame: 10, 20 weeks and endpoint
6 secondary outcomes
Change from baseline in Clinical Global Impression - Severity (CGI-S)
Time frame: 10 , 20 weeks and endpoint
Change from baseline in Beck Depression Inventory (BDI)
Time frame: 10 , 20 weeks and endpoint
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 10, 20 weeks and endpoint
Change from baseline in Schizophrenia Quality of Life Scale (SQLS)
Time frame: 10, 20 weeks and endpoint
Change from baseline in Simpson-Angus Scale (SAS)
Time frame: 5, 10, 15, 20 weeks, endpoint
Change from baseline in Clozapine Adverse Effects Inventory (CAEI)
Time frame: 5, 10 ,15, 20 weeks, endpoint
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 9 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clozapine, Amisulpride and Clozapine+Amisulpride in people with Schizophrenia and Treatment Resistant Disorders, run by Geha Mental Health Center at 1 site 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 7 inclusion and 5 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 9 Dec 2015. 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 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.
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?
Change from baseline in Positive and Negative Syndrome Scale (PANSS) (time frame: 10, 20 weeks and endpoint). 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 9 Dec 2015.