Treatment-resistant SchizophreniaPhase 4M1106NCT01105481
Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients
A Phase 4 study testing Amisulpride add-on in people with Treatment-resistant Schizophrenia, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
This study includes two main components: the first screening phase and the second clinical intervention phase. During the screening phase, subjects with poor response to clozapine are carefully evaluated by chart-review and clinical assessment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment-resistant Schizophrenia
- What is being tested?
- Amisulpride add-on
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 2 sitesTaiwan
- Study dates
- May 2006to Jun 2008
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosed schizophrenic patients;
- Age between 18 and 60;
- Before treatment with clozapine, documented treatment failure of two antipsychotics for an adequate duration of 6 weeks and in a sufficient dose of 600 mg/day of chlorpromazine equivalents;
- Documented failure to show a satisfactory clinical response to an adequate clozapine treatment, defined as at least clozapine 300 mg/day for 3 months or a plasma drug level of 350ng/ml;
- At least moderately ill, defined as with a Clinical Global Impression (CGI) greater than 4 or PANSS total score greater than 75;
- Persistent positive psychotic symptoms, with rating scores of moderate or worse on at least two of four positive symptom items (delusion, conceptual disorganization, hallucinatory behavior, and suspiciousness/persecution) on Positive and Negative Syndrome Scale (PANSS);
Who cannot join
- Patients with concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ;
- Patients with underlying severe medical illness, such as cardiovascular disease, cerebrovascular disease, bone marrow suppression or epilepsy;
- Patients with comorbid diagnosis of substance dependence;
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Bali Psychiatric Center
Taipei County
Departments of Psychiatry, Tao-yuan Psychiatric Center
Taoyuan
About this study
Official title: Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients: A 14-week Randomized, Double-blind and Placebo-controlled Trial
This study includes two main components: the first screening phase and the second clinical intervention phase. During the screening phase, subjects with poor response to clozapine are carefully evaluated by chart-review and clinical assessment. Via chart-review, clinical data of diagnosis, disease course and previous treatment outcome, and concomitant psychotropic agents are obtained. Clinical phenomenology, including psychopathology, psychotic and mood symptoms severity and side effect of psychotropic medication are assessed by clinical interview and observation, which are conducted by experienced clinicians. Blood sample will be also obtained from the subjects for measuring the baseline clozapine drug level and extracting DNA for further analysis. Subjects fulfilling the criteria of treatment-resistant schizophrenia with poor response to adequate dose and duration of clozapine treatment are eligible for the clinical trial phase of 14-week randomized, placebo-controlled amisulpride add-on study. In this phase, subjects are randomly allocated to amisulpride augmentation treatment group and placebo treatment group. Subjects in the former group will receive clozapine and amisulpride combination treatment, while in the latter group will receive clozapine and placebo. Outcomes of clinical efficacy and safety are carefully evaluated by experienced and well-trained research stuffs in the 14 weeks of clinical study period.
All of the above studies will be conducted in four hospitals, including DOH Bali Psychiatric Hospital, DOH Tao-yan Psychiatric hospital, and the Ju-Shang Psychiatric Hospital. Subjects will be recruited from the chronic in-patient settings from these three hospitals.
- Conditions
- Treatment-resistant Schizophrenia
- Being tested
- Amisulpride add-on, Placebo add-on
- Keywords
- treatment-resistant schizophrenia, clozapine, amisulpride
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride add-onDrug
At the beginning of the treatment phase (day 1), subjects in the combination treatment group will be started with adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. All of the add-on amisulpride will be provided to subjects at night. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.
Placebo add-onDrug
For subjects randomly allocated to the placebo treatment group, they will be added with one capsule of placebo from Day 1. On Day 8, Day 15 and Day 22, the placebo will be increased to 2, 3 and 4 capsules, respectively. and adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.
| Study group | Role | What they receive |
|---|---|---|
| amisulpride add-on | Experimental | Not described Receives: Drug: Amisulpride add-on |
| placebo add-on | Placebo comparator | Not described Receives: Drug: Placebo add-on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale(PANSS) total score change
The change from baseline of the Positive and Negative Symptom Scale (PANSS) total score.
Measured: 12 wks after treatment
Secondary outcomes (5)
Positive and Negative Symptom Scale (PANSS) positive-symptom subscale score
The change from baseline of the Positive and Negative Symptom Scale (PANSS) positive-symptom subscale score (sum of item P1 to P7)
Measured: 12 wks after treatment
Positive and Negative Symptom Scale (PANSS) negative-symptom subscale score
The change from baseline of the Positive and Negative Symptom Scale (PANSS) negative-symptom subscale score (sum of item N1 to N7)
Measured: 12 wks after treatment
Positive and Negative Symptom Scale (PANSS) general psychopathology score
The change from baseline of the Positive and Negative Symptom Scale (PANSS) general psychopathology subscale score (sum of item G1 to G14)
Measured: 12 wks after treatment
Clinical Global Impressions (CGI) scale score
The change from baseline of the Clinical Global Impressions (CGI) scale score
Measured: 12 wks after treatment
Brief Psychotic Rating Scale (BPRS) total score
The change from baseline of the Brief Psychotic Rating Scale (BPRS) score
Measured: 12 wks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMay 2006
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Investigators
- Sheng-Chang Wang, M.D.,M.Sc., Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105481
- Sponsor's protocol ID
- M1106
- Acronym
- M1106
- Status last verified
- Apr 2010
- First submitted
- 31 Mar 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients: A 14-week Randomized, Double-blind and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01105481
- Acronym / sponsor ID
- M1106 / M1106
- Conditions
- Treatment-resistant Schizophrenia
- Keywords
- treatment-resistant schizophrenia, clozapine, amisulpride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Apr 2010 (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.
This study includes two main components: the first screening phase and the second clinical intervention phase. During the screening phase, subjects with poor response to clozapine are carefully evaluated by chart-review and clinical assessment. Via chart-review, clinical data of diagnosis, disease course and previous treatment outcome, and concomitant psychotropic agents are obtained. Clinical phenomenology, including psychopathology, psychotic and mood symptoms severity and side effect of psychotropic medication are assessed by clinical interview and observation, which are conducted by experienced clinicians. Blood sample will be also obtained from the subjects for measuring the baseline clozapine drug level and extracting DNA for further analysis. Subjects fulfilling the criteria of treatment-resistant schizophrenia with poor response to adequate dose and duration of clozapine treatment are eligible for the clinical trial phase of 14-week randomized, placebo-controlled amisulpride add-on study. In this phase, subjects are randomly allocated to amisulpride augmentation treatment group and placebo treatment group. Subjects in the former group will receive clozapine and amisulpride combination treatment, while in the latter group will receive clozapine and placebo. Outcomes of clinical efficacy and safety are carefully evaluated by experienced and well-trained research stuffs in the 14 weeks of clinical study period.
All of the above studies will be conducted in four hospitals, including DOH Bali Psychiatric Hospital, DOH Tao-yan Psychiatric hospital, and the Ju-Shang Psychiatric Hospital. Subjects will be recruited from the chronic in-patient settings from these three hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amisulpride add-on | Experimental | Drug: Amisulpride add-on |
| placebo add-on | Placebo comparator | Drug: Placebo add-on |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DSM-IV diagnosed schizophrenic patients;
- Age between 18 and 60;
- Before treatment with clozapine, documented treatment failure of two antipsychotics for an adequate duration of 6 weeks and in a sufficient dose of 600 mg/day of chlorpromazine equivalents;
- Documented failure to show a satisfactory clinical response to an adequate clozapine treatment, defined as at least clozapine 300 mg/day for 3 months or a plasma drug level of 350ng/ml;
- At least moderately ill, defined as with a Clinical Global Impression (CGI) greater than 4 or PANSS total score greater than 75;
Key exclusion criteria (3 listed)
- Patients with concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ;
- Patients with underlying severe medical illness, such as cardiovascular disease, cerebrovascular disease, bone marrow suppression or epilepsy;
- Patients with comorbid diagnosis of substance dependence;
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 |
|---|---|---|
| Amisulpride add-onAt the beginning of the treatment phase (day 1), subjects in the combination treatment group will be started with adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. All of the add-on amisulpride will be provided to subjects at night. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo. | Drug | amisulpride add-on |
| Placebo add-onFor subjects randomly allocated to the placebo treatment group, they will be added with one capsule of placebo from Day 1. On Day 8, Day 15 and Day 22, the placebo will be increased to 2, 3 and 4 capsules, respectively. and adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo. | Drug | placebo add-on |
Primary outcome
Positive and Negative Symptom Scale(PANSS) total score change
Time frame: 12 wks after treatment
The change from baseline of the Positive and Negative Symptom Scale (PANSS) total score.
5 secondary outcomes
Positive and Negative Symptom Scale (PANSS) positive-symptom subscale score
Time frame: 12 wks after treatment
Positive and Negative Symptom Scale (PANSS) negative-symptom subscale score
Time frame: 12 wks after treatment
Positive and Negative Symptom Scale (PANSS) general psychopathology score
Time frame: 12 wks after treatment
Clinical Global Impressions (CGI) scale score
Time frame: 12 wks after treatment
Brief Psychotic Rating Scale (BPRS) total score
Time frame: 12 wks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
Related trials for Treatment-resistant Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Not yet recruitingPhase 3
Stratification and Treatment in Early Psychosis Study -ASSIST
Treatment Resistant Psychosis, Psychosis
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
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.
Sheng-Chang Wang, M.D.,M.Sc. principal investigator
National Health Research Institutes, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amisulpride add-on in people with Treatment-resistant Schizophrenia, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
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 6 inclusion and 3 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 16 Apr 2010. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Symptom Scale(PANSS) total score change (time frame: 12 wks after treatment). 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 16 Apr 2010.