Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00328367
First received: May 17, 2006
Last updated: October 28, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: aripiprazole Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Randomized Placebo Controlled Study of Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Serum Prolactin Level [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Body Mass Index & Abdominal Circumference [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Lipid Panel with LDL Cholesterol [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- FBS-PP & HbA1c [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical Global Impression-Severity & Improvement (CGI-S & CGI-I) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Subjective Well-being under Neuroleptics scale (SWN) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Udvalg Fur Kliniske Undersogesler (UKU) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Blood Pressure and Pulse Rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Admission Battery, CBC, & EKG [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Serum Clozapine Level [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Quantitative Electroencephalogram [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Enrollment: | 61 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
clozapine plus aripiprazole
|
Drug: aripiprazole
aripiprazole augmentation of clozapine
Other Names:
|
|
Placebo Comparator: B
clozapine plus placebo
|
Drug: placebo
placebo
Other Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328367
Locations
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
Seoul National University Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
| Principal Investigator: | Yong Sik Kim, MD, PhD | Seoul National University Hospital |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yong Sik Kim/Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00328367 History of Changes |
| Other Study ID Numbers: | KYS-2006-05209 |
| Study First Received: | May 17, 2006 |
| Last Updated: | October 28, 2008 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Seoul National University Hospital:
|
schizophrenia aripiprazole clozapine |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents |
ClinicalTrials.gov processed this record on May 16, 2013