Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia

This study has been completed.
Sponsor:
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

May 17, 2006
October 28, 2008
December 2005
December 2006   (final data collection date for 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 ] [ 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 ]
  • Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint.
  • 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.
Complete list of historical versions of study NCT00328367 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical Global Impression-Severity & Improvement (CGI-S & CGI-I): Clinical improvement will be measured by changes in CGI-S and CGI-I scores from baseline to 8th week endpoint.
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Yale-Brown Obsessive Compulsive Scale (YBOCS)
  • Subjective Well-being under Neuroleptics scale (SWN)
  • Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)
  • Udvalg Fur Kliniske Undersogesler (UKU)
  • Body Mass Index and Abdominal Circumference
  • Blood Pressure and Pulse Rate
  • Admission Battery, CBC, EKG, Lipid Panel with LDL cholesterol, FBS-PP2, HbA1c, and serum PRL level:
  • Serum Clozapine Level
  • Quantitative Electroencephalogram:baseline, week 1, and week 8
Not Provided
Not Provided
 
Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: aripiprazole
    aripiprazole augmentation of clozapine
    Other Names:
    • abilify
    • OPC-14597
  • Drug: placebo
    placebo
    Other Name: placebo
  • Experimental: A
    clozapine plus aripiprazole
    Intervention: Drug: aripiprazole
  • Placebo Comparator: B
    clozapine plus placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
February 2008
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00328367
KYS-2006-05209
Yes
Yong Sik Kim/Professor, Seoul National University Hospital
Seoul National University Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
Principal Investigator: Yong Sik Kim, MD, PhD Seoul National University Hospital
Seoul National University Hospital
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP