NCT00480844

Brief Summary

In this study we intend to compare the effect of Sertindole to that of Risperidone on cognitive impairment in schizophrenia. Hypothesis: Sertindole will be as effective as Risperidone for treating cognitive impairment in schizophrenia and with fewer side effects.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

3 years

First QC Date

May 30, 2007

Last Update Submit

March 24, 2009

Conditions

Schizophrenia

Keywords

schizophreniaSertindoleRisperidonecognitive impairment

Outcome Measures

Primary Outcomes (1)

  • cognitive functioning

    24 weeks

Secondary Outcomes (1)

  • Discontinuation due to all causes, symptomatology and adverse events.

    24 weeks

Study Arms (2)

Sertindole

EXPERIMENTAL
Drug: Sertindole

Risperidone

ACTIVE COMPARATOR
Drug: Risperidone

Interventions

SertindoleDRUG

Oral (tablets), 16-24 mg QD (once a day) for 12 weeks.

Also known as: Serdolect
Sertindole
RisperidoneDRUG

Oral (tablets), 4-8 mg QD (once a day) for 12 weeks.

Also known as: Rispond, Risperdal, Risperidex
Risperidone

Eligibility Criteria

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

You may qualify if:

  • Patients suffering from Schizophrenia (DSM IV).
  • Failure of at least one previous antipsychotic for intolerance.
  • Psychotic symptoms that are not secondary to a general medical condition or substance abuse.
  • Ages between 18-65 years old.
  • Patients receiving other psychotropic medications (anti-depressants, mood stabilizers, sedatives, hypnotics) must be on a stable dose for at least 2 weeks before entering the trial.
  • Able to understand and sign an informed consent form.

You may not qualify if:

  • Patients suffering from psychotic disorders caused by a general medical condition.
  • Patients having high suicidal risk, as measured by score of 2 or more in CDSS - Calgary Depression Scale for Schizophrenia.
  • Patients suffering from an unstable clinically significant medical condition (endocrine, nutritional, hepatic, urinary).
  • Significant cardiovascular illness, and/or QT prolongation at screening (more then 450 msec for male or 470 msec for female).
  • Patients suffering from a malignancy or neuro-degenerative illness (e.g. Parkinsons' Disease)
  • Patients suffering from organic brain disorders, including epilepsy and mental retardation.
  • Patients suffering from a clinically significant mood disorder.
  • Pregnancy.
  • History of drug or alcohol dependence within the last year.
  • Previous documented non-response to Risperidone.
  • Patients using medicinal products that are contraindicated with sertindole and/or Risperidone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Psychiatry of the Sheba Medical Center

Ramat Gan, Tel Hashomer, 52621, Israel

RECRUITING

Beer-Yaakov Mental Health Center

Beer-Yaakov, 70350, Israel

NOT YET RECRUITING

Kfar Shaul Mental Health Center

Jerusalem, 91060, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Interventions

sertindoleRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mark Weiser, Dr

    Shaba Medical Center, Tel-Aviv University Sackler School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Weiser, Dr

CONTACT

03-5303773mweiser@netvision.net.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

October 1, 2008

Primary Completion

October 1, 2011

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

IL(3)