NCT02137993

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4 schizophrenia

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

March 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

May 11, 2014

Last Update Submit

May 11, 2014

Conditions

SchizophreniaSchizophreniform DisorderSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline at 6 week in total PANSS score

    6 week

Secondary Outcomes (4)

  • Change from baseline at 1, 2, 4 and 6 week in total PANSS score.

    6 week

  • Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week

    6 week

  • Change from baseline at 6 week in total CGI-S score

    6 week

  • Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'

    6 week

Study Arms (2)

A-prexa

EXPERIMENTAL

A-prexa 5, 10mg

Drug: Zyprexa

Zyprexa

ACTIVE COMPARATOR

Zyprexa 5, 10mg

Drug: A-prexa

Interventions

A-prexaDRUG

A-prexa 5-20 mg for 6 weeks

Zyprexa
ZyprexaDRUG

Zyprexa 5-20 mg for 6 weeks

A-prexa

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years to 65 years
  • Schizophrenia patient with an acute exacerbation
  • Understand the requirement of the study and voluntarily consent to participate in the study

You may not qualify if:

  • Patients who have another psychiatric disorders
  • Patients who have unstable medical conditions
  • Patients who have clinically important abnormalities of liver function test (\>2.5 fold of upper normal limit), ECG and vital sign at screening visit
  • Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
  • Patients who have a history of an allergic reaction to olanzapine
  • Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
  • Patient who take clozapine within 12 weeks before screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2014

First Posted

May 14, 2014

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 14, 2014

Record last verified: 2014-05