Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents

This study has been completed.
Sponsor:
Collaborators:
National Science Council, Taiwan
Taoyuan Mental Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00545467
First received: October 15, 2007
Last updated: May 16, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to determine whether moderately ill Asian schizophrenic patients can be switched from their previous antipsychotic medication to aripiprazole with minimal adverse clinical consequences, and elucidate both pharmacokinetic and pharmacodynamic factors associated with clinical efficacy of aripiprazole.


Condition Intervention Phase
DSM-IV Schizophrenia
Schizoaffective Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents: Combination of Pharmacogenomics and Therapeutic Drug Monitoring

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Treatment efficacy was assessed using PNASS, Clinical Global Impression (CGI) Scale, and EPS rating scales [ Time Frame: on days 0, 7, 14, 28, 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HPLC analysis Genotyping [ Time Frame: on days 0, 14, 56 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks
Drug: Aripiprazole
Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
Other Name: abilify
Active Comparator: 2
slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks
Drug: Aripiprazole
Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
Other Name: abilify

Detailed Description:

Aripiprazole (commercial name abilify) is the first commercially available drug with dopamine partial agonist effects approved for the treatment of schizophrenia and bipolar disorder since 2002 in the U.S. It reduces negative symptoms of schizophrenia efficiently and has a markedly lower incidence of extrapyramidal symptoms and tardive dyskinesia. However, the process of switching other antipsychotic agents to aripiprazole can result in a re-emergence or worsening of psychosis, along with unpleasant side effects such as insomnia, nausea, vomiting, anxiety and agitation. On the basis of a prior study demonstrating the efficacy and safety of aripiprazole in Taiwan population, we hence propose to apply a combined use of pharmacogenomics and therapeutic drug monitoring in the evaluation of the strategies of switching stable schizophrenia patients to aripiprazole from other antipsychotic agents.

We will evaluate their cytochrome P450 background along with other potential candidate genes of schizophrenia. This 2-year proposal will examine the relative efficacy, safety and tolerability of two different strategies for switching stable inpatients/outpatients from prior antipsychotic monotherapy to aripiprazole 15 mg/day monotherapy using two different strategies:

  1. Fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks.
  2. Slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks.

A total of 200 stable schizophrenia patients will be randomized with open label to two strategies.

We expect to achieve the following results:

  1. Developing a protocol that has high probability of switching successfully schizophrenia patients to aripiprazole, which is effective in treatment refractory cases and has a markedly lower incidence of severe side effects, from other antipsychotics.
  2. Elucidate both pharmacokinetic and pharmacodynamic factors associated with clinical efficacy of aripiprazole.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and non-lactating, non-pregnant women who are aged 18 to 65 years
  • primary diagnosis of DSM-IV schizophrenia or schizoaffective disorder
  • taking a stabilized dose of a single oral antipsychotic for at least 1 month prior to study entry
  • cannot have been hospitalized for an exacerbation of schizophrenia or schizoaffective disorder for at least 2 months

Exclusion Criteria:

  • having other psychiatric disorders
  • hospitalizing for acute exacerbation of patients' condition within 2 months
  • having taken a selective serotonin reuptake inhibitor (SSRI) within 4 weeks of screening
  • a first episode of schizophrenia or schizoaffective disorder
  • a clinically significant neurological abnormality other than tardive dyskinesia or EPS
  • current diagnosis of psychoactive substance dependence or a historical drug or alcohol abuse within 1 month before the beginning of the study
  • treatment with an investigational drug within 4 weeks prior to randomization
  • requiring to take medication that inhibits the microsomal enzyme CYP2D6 or inhibits or acts as a substrate for CYP3A4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545467

Locations
Taiwan
Department of Psychiatry, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Taoyuan Mental Hospital
Investigators
Study Chair: Tzung-Jeng Hwang, MD Department of Psychiatry, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00545467     History of Changes
Other Study ID Numbers: 200705030M
Study First Received: October 15, 2007
Last Updated: May 16, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Aripiprazole
schizophrenia
antipsychotics
pharmacogenomics
cytochrome P450 enzyme

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014