SchizophreniaPhase 4NCT00328367
Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
A Phase 4 study testing aripiprazole in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether aripiprazole augmentation is safe and effective in the treatment of clozapine-treated patients with refractory schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- aripiprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2005to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 18-65 years of age.
- Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
- Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
- Patients must have a baseline (day 0) BPRS score of at least 35 or over 2 of 5 SANS global rating item scores of at least 3.
- Patients have been receiving clozapine treatment for more than 1 year and there has been no change in clozapine dosage for more than 3 months.
- Patients must have a history of antipsychotic treatment with at least 2 different kinds prior to clozapine administration.
- Subjects who are fluent in Korean.
Who cannot join
- DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
- Female patients who are either pregnant or lactating.
- Mental retardation (IQ < 70).
- Neurological disorders including epilepsy, stroke, or severe head trauma.
- Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
- Prior history of aripiprazole non-response or intolerance.
Show all 11Show fewer
- BPRS score of < 35 and over 4 of 5 SANS global rating item scores of < 3.
- Participation in a clinical trial of another investigational drug within 3 months (90 days) prior to study entry.
- Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline (day 0).
- History of electroconvulsive therapy within the past 3 months.
- Subjects who are not fluent in Korean.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Randomized Placebo Controlled Study of Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
The purpose of this study is to determine whether aripiprazole augmentation is safe and effective in the treatment of clozapine-treated patients with refractory schizophrenia.
Read the detailed description
Clozapine is renowned for its efficacy in treating schizophrenia refractory to typical or atypical antipsychotics. Though the effectiveness of clozapine has been established, a considerable number of patients with schizophrenia are partially responsive or unresponsive to clozapine. In addition, long-term use of clozapine is associated with the development of obsessive-compulsive symptoms and metabolic syndrome. In order to overcome these short-comings and to increase efficacy, aripiprazole augmentation was implemented. Quantitative electroencephalogram will be used to monitor the occurrence of abnormal findings and to analyze the changes in electroencephalographic pattern with linear and non-linear methodology.
Comparisons: Design of double-blind randomized placebo controlled study of patients at Refractory Schizophrenia Clinique in Department of Neuropsychiatry at Seoul National University Hospital.
- Conditions
- Schizophrenia
- Being tested
- aripiprazole, placebo
- Keywords
- schizophrenia, aripiprazole, clozapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called abilify, OPC-14597
aripiprazole augmentation of clozapine
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | clozapine plus aripiprazole Receives: Drug: aripiprazole |
| B | Placebo comparator | clozapine plus placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point.
Measured: one year
Schedule for Assessment of Negative Symptoms (SANS): Measure of efficacy will be changes in SANS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made at 6 month and 12 month after 8th week end point.
Measured: one year
Serum Prolactin Level
Measured: one year
Body Mass Index & Abdominal Circumference
Measured: one year
Lipid Panel with LDL Cholesterol
Measured: one year
FBS-PP & HbA1c
Measured: one year
Secondary outcomes (10)
Clinical Global Impression-Severity & Improvement (CGI-S & CGI-I)
Measured: one year
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: one year
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Measured: one year
Subjective Well-being under Neuroleptics scale (SWN)
Measured: one year
Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)
Measured: one year
Udvalg Fur Kliniske Undersogesler (UKU)
Measured: one year
Blood Pressure and Pulse Rate
Measured: one year
Admission Battery, CBC, & EKG
Measured: one year
Serum Clozapine Level
Measured: one year
Quantitative Electroencephalogram
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Yong Sik Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328367
- Sponsor's protocol ID
- KYS-2006-05209
- Status last verified
- Apr 2008
- First submitted
- 17 May 2006
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rocha FL, Hara C. Benefits of combining aripiprazole to clozapine: three case reports. Prog Neuropsychopharmacol Biol Psychiatry. 2006 Aug 30;30(6):1167-9. doi: 10.1016/j.pnpbp.2006.03.024. Epub 2006 May 2.
PubMed 16647796Henderson DC, Kunkel L, Nguyen DD, Borba CP, Daley TB, Louie PM, Freudenreich O, Cather C, Evins AE, Goff DC. An exploratory open-label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia. Acta Psychiatr Scand. 2006 Feb;113(2):142-7. doi: 10.1111/j.1600-0447.2005.00612.x.
PubMed 16423166Ziegenbein M, Sieberer M, Calliess IT, Kropp S. Combination of clozapine and aripiprazole: a promising approach in treatment-resistant schizophrenia. Aust N Z J Psychiatry. 2005 Sep;39(9):840-1. doi: 10.1111/j.1440-1614.2005.01688_2.x. No abstract available.
PubMed 16168043Chang JS, Ahn YM, Park HJ, Lee KY, Kim SH, Kang UG, Kim YS. Aripiprazole augmentation in clozapine-treated patients with refractory schizophrenia: an 8-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2008 May;69(5):720-31. doi: 10.4088/jcp.v69n0505.
PubMed 18370574
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Placebo Controlled Study of Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT00328367
- Acronym / sponsor ID
- KYS-2006-05209
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, aripiprazole, clozapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 May 2006 (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.
The purpose of this study is to determine whether aripiprazole augmentation is safe and effective in the treatment of clozapine-treated patients with refractory schizophrenia.
Detailed description
Clozapine is renowned for its efficacy in treating schizophrenia refractory to typical or atypical antipsychotics. Though the effectiveness of clozapine has been established, a considerable number of patients with schizophrenia are partially responsive or unresponsive to clozapine. In addition, long-term use of clozapine is associated with the development of obsessive-compulsive symptoms and metabolic syndrome. In order to overcome these short-comings and to increase efficacy, aripiprazole augmentation was implemented. Quantitative electroencephalogram will be used to monitor the occurrence of abnormal findings and to analyze the changes in electroencephalographic pattern with linear and non-linear methodology.
Comparisons: Design of double-blind randomized placebo controlled study of patients at Refractory Schizophrenia Clinique in Department of Neuropsychiatry at Seoul National University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: aripiprazoleclozapine plus aripiprazole |
| B | Placebo comparator | Drug: placeboclozapine plus placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, 18-65 years of age.
- Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
- Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
- Patients must have a baseline (day 0) BPRS score of at least 35 or over 2 of 5 SANS global rating item scores of at least 3.
Key exclusion criteria (11 listed)
- DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
- Female patients who are either pregnant or lactating.
- Mental retardation (IQ < 70).
- Neurological disorders including epilepsy, stroke, or severe head trauma.
- Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
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 |
|---|---|---|
| aripiprazoleAlso: abilify, OPC-14597aripiprazole augmentation of clozapine | Drug | A |
| placeboplacebo | Drug | B |
Primary outcome
Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point.
Time frame: one year
Schedule for Assessment of Negative Symptoms (SANS): Measure of efficacy will be changes in SANS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made at 6 month and 12 month after 8th week end point.
Time frame: one year
Serum Prolactin Level
Time frame: one year
Body Mass Index & Abdominal Circumference
Time frame: one year
Lipid Panel with LDL Cholesterol
Time frame: one year
FBS-PP & HbA1c
Time frame: one year
10 secondary outcomes
Clinical Global Impression-Severity & Improvement (CGI-S & CGI-I)
Time frame: one year
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: one year
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: one year
Subjective Well-being under Neuroleptics scale (SWN)
Time frame: one year
Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)
Time frame: one year
Udvalg Fur Kliniske Undersogesler (UKU)
Time frame: one year
Blood Pressure and Pulse Rate
Time frame: one year
Admission Battery, CBC, & EKG
Time frame: one year
Serum Clozapine Level
Time frame: one year
Quantitative Electroencephalogram
Time frame: one year
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 29 Oct 2008.
- Background: PubMed 16647796Rocha FL, Hara C. Benefits of combining aripiprazole to clozapine: three case reports. Prog Neuropsychopharmacol Biol Psychiatry. 2006 Aug 30;30(6):1167-9. doi: 10.1016/j.pnpbp.2006.03.024. Epub 2006 May 2.
- Background: PubMed 16423166Henderson DC, Kunkel L, Nguyen DD, Borba CP, Daley TB, Louie PM, Freudenreich O, Cather C, Evins AE, Goff DC. An exploratory open-label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia. Acta Psychiatr Scand. 2006 Feb;113(2):142-7. doi: 10.1111/j.1600-0447.2005.00612.x.
- Background: PubMed 16168043Ziegenbein M, Sieberer M, Calliess IT, Kropp S. Combination of clozapine and aripiprazole: a promising approach in treatment-resistant schizophrenia. Aust N Z J Psychiatry. 2005 Sep;39(9):840-1. doi: 10.1111/j.1440-1614.2005.01688_2.x. No abstract available.
- Derived from this study: PubMed 18370574Chang JS, Ahn YM, Park HJ, Lee KY, Kim SH, Kang UG, Kim YS. Aripiprazole augmentation in clozapine-treated patients with refractory schizophrenia: an 8-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2008 May;69(5):720-31. doi: 10.4088/jcp.v69n0505.
- Click here for detailed information about aripiprazole.Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Yong Sik Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aripiprazole in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
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 8 inclusion and 11 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 29 Oct 2008. 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 South Korea. 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?
Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point. (time frame: one year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328367, which also lists 4 linked publications.
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 29 Oct 2008.