Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia

NCT00328367 | Completed Phase 4 DMC

• 1 other identifier: KYS-2006-05209
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

schizophrenia; aripiprazole; clozapine

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  one year

• Serum Prolactin Level

  one year

• Body Mass Index & Abdominal Circumference

  one year

• Lipid Panel with LDL Cholesterol

  one year

• FBS-PP & HbA1c

  one year

Secondary Outcomes (10)

• Clinical Global Impression-Severity & Improvement (CGI-S & CGI-I)

  one year

• Montgomery-Asberg Depression Rating Scale (MADRS)

  one year

• Yale-Brown Obsessive Compulsive Scale (YBOCS)

  one year

• Subjective Well-being under Neuroleptics scale (SWN)

  one year

• Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)

  one year

Study Arms (2)

A

EXPERIMENTAL

clozapine plus aripiprazole

Drug: aripiprazole

B

PLACEBO COMPARATOR

clozapine plus placebo

Drug: placebo

Interventions

aripiprazole DRUG

aripiprazole augmentation of clozapine

Also known as: abilify, OPC-14597

A

placebo DRUG

placebo

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (4)

• 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.

  PMID: 16647796 BACKGROUND

• Henderson 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.

  PMID: 16423166 BACKGROUND

• Ziegenbein 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.

  PMID: 16168043 BACKGROUND

• Chang 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.

  PMID: 18370574 DERIVED

Related Links

• Click here for detailed information about aripiprazole.

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yong Sik Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 19, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2008
• Last Updated: October 29, 2008

Record last verified: 2008-04

Locations

KR (1)