NCT00545467

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 17, 2012

Status Verified

January 1, 2012

Enrollment Period

1.8 years

First QC Date

October 15, 2007

Last Update Submit

May 16, 2012

Conditions

DSM-IV SchizophreniaSchizoaffective Disorder

Keywords

Aripiprazoleschizophreniaantipsychoticspharmacogenomicscytochrome P450 enzyme

Outcome Measures

Primary Outcomes (1)

  • Treatment efficacy was assessed using PNASS, Clinical Global Impression (CGI) Scale, and EPS rating scales

    on days 0, 7, 14, 28, 56

Secondary Outcomes (1)

  • HPLC analysis Genotyping

    on days 0, 14, 56

Study Arms (2)

1

ACTIVE COMPARATOR

fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks

Drug: Aripiprazole

2

ACTIVE COMPARATOR

slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks

Drug: Aripiprazole

Interventions

AripiprazoleDRUG

Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.

Also known as: abilify
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (2)

  • Ma CH, Chan HY, Hsieh MH, Liu CC, Liu CM, Hwu HG, Kuo CH, Chen WJ, Hwang TJ. Identifying dopamine supersensitivity through a randomized controlled study of switching to aripiprazole from other antipsychotic agents in patients with schizophrenia. Ther Adv Psychopharmacol. 2022 Jan 28;12:20451253211064396. doi: 10.1177/20451253211064396. eCollection 2022.

    PMID: 35111295DERIVED

  • Jen YW, Hwang TJ, Chan HY, Hsieh MH, Liu CC, Liu CM, Hwu HG, Kuo CH, Lin YT, Chien YL, Chen WJ. Abnormally low prolactin levels in schizophrenia patients after switching to aripiprazole in a randomized trial: a biomarker for rebound in psychotic symptoms? BMC Psychiatry. 2020 Nov 23;20(1):552. doi: 10.1186/s12888-020-02957-7.

    PMID: 33228575DERIVED

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tzung-Jeng Hwang, MD

    Department of Psychiatry, National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 17, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

May 17, 2012

Record last verified: 2012-01

Locations

TW(1)