NCT02192723

Brief Summary

The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 15, 2014

Last Update Submit

July 10, 2016

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS)

    Baseline, 8 weeks

Secondary Outcomes (1)

  • Clinical Global Impression (CGI)

    Baseline, 8 weeks

Other Outcomes (1)

  • Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale

    Baseline, 8 weeks

Study Arms (6)

Typical antipsychotic

EXPERIMENTAL

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day) for 8 weeks.

Drug: Typical antipsychotic

Risperidone

ACTIVE COMPARATOR

Risperidone, 2\~6mg/day, twice day, 8 weeks

Drug: Risperidone

Olanzapine

ACTIVE COMPARATOR

5\~20mg/day

Drug: Olanzapine

Quetiapine

ACTIVE COMPARATOR

400\~750mg/day

Drug: Quetiapine

Aripiprazole

ACTIVE COMPARATOR

Aripiprazole, 10\~30mg/day, twice per day, 8 weeks

Device: Aripiprazole

Ziprasidone

ACTIVE COMPARATOR

Ziprasidone, 80\~160mg/day, twice per day, 8 weeks

Drug: Ziprasidone

Interventions

Typical antipsychoticDRUG

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day), twice per day, 8 weeks

Also known as: Haldol and Trilafon
Typical antipsychotic
RisperidoneDRUG

2\~6mg/day, twice per day, 8 weeks

Also known as: Risperdal
Risperidone
OlanzapineDRUG

Olanzapine, 400\~750mg/day, twice per day, 8 weeks

Also known as: Zyprexa
Olanzapine
QuetiapineDRUG

Quetiapine, 400～750mg/day, twice per day, 8 weeks

Also known as: Seroquel
Quetiapine
AripiprazoleDEVICE

Aripiprazole, 10～30mg/day, twice per day, 8 weeks

Also known as: Abilify
Aripiprazole
ZiprasidoneDRUG

Ziprasidone 80\~160mg/day, twice per day, 8 weeks

Also known as: Geodon
Ziprasidone

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes.
  • Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients.
  • A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, 100096, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

HaloperidolPerphenazineRisperidoneOlanzapineQuetiapine Fumarateziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic ChemicalsPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingDibenzothiazepinesThiazepinesThiepins

Study Officials

  • Zhi-Ren Wang, MD, PhD

    Beijing HuiLongGuan Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, the Research Center

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CN(1)