NCT00864045

Brief Summary

The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
394

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_3 schizophrenia

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

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

March 17, 2009

Last Update Submit

September 19, 2013

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.

    12 weeks

Secondary Outcomes (1)

  • To evaluate the safety and tolerability of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.

    12 weeks

Study Arms (2)

Sertindole

EXPERIMENTAL
Drug: Sertindole

Olanzapine

ACTIVE COMPARATOR
Drug: Olanzapine

Interventions

SertindoleDRUG

Sertindole flexible doses per os, 12, 16 or 20mg/day according to response and tolerability, initially up-titrated from 4mg/day to target dose 16mg/day within the first 16 days

Sertindole
OlanzapineDRUG

Olanzapine flexible doses per os, 10, 15 or 20mg/day according to response and tolerability, initially up-titrated from 10mg/day to target dose 15mg/day within the first 16 days

Olanzapine

Eligibility Criteria

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

You may qualify if:

  • Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
  • Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline
  • Based on the patient's clinical status, an antipsychotic treatment is indicated
  • Otherwise healthy
  • Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods

You may not qualify if:

  • Current Axis I primary psychiatric diagnosis other than schizophrenia
  • Has never before received antipsychotic drugs
  • Has received a depot antipsychotic medication within less than one dose interval prior to Screening
  • History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (\<50 beats per minute)
  • Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening)
  • Significant risk of suicide and/or violent behaviour
  • Known history of narrow angle glaucoma
  • Substance or alcohol abuse, current alcohol dependence
  • Use of disallowed concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CN001

Beijing, 300074, China

Location

Related Publications (1)

  • Kim EY, Chang SM, Shim JC, Joo EJ, Kim JJ, Kim YS, Ahn YM. Long-term effectiveness of flexibly dosed paliperidone extended-release: comparison among patients with schizophrenia switching from risperidone and other antipsychotic agents. Curr Med Res Opin. 2013 Oct;29(10):1231-40. doi: 10.1185/03007995.2013.816277. Epub 2013 Jul 16.

    PMID: 23777311DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindoleOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

CN(1)