NCT00345982

Brief Summary

The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable 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

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

4 years

First QC Date

June 28, 2006

Last Update Submit

September 24, 2010

Conditions

Schizophrenia

Keywords

SchizophreniaTreatment-resistantsertindoleclozapine

Outcome Measures

Primary Outcomes (1)

  • PANSS total score

    12 weeks

Secondary Outcomes (8)

  • GAF

    12 weeks

  • WHOQOL-BREF

    12 weeks

  • CGI

    12 weeks

  • DAI

    12 weeks

  • Cognitive test

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Sertindole 16 mg

Drug: Serdolect

B

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

SerdolectDRUG

16 mg, 12 weeks

Also known as: sertindole
A
placeboDRUG

placebo

B

Eligibility Criteria

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

You may qualify if:

  • ICD10 diagnosis of schizophrenia (F20.0-3)
  • Clozapine treatment minimum 6 months
  • Total PANSS \>65

You may not qualify if:

  • QTc \>500 ms
  • Violence to SPC of clozapine or Serdolect
  • Major depression
  • Significant substance misuse interfering with participating in the study
  • Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Psychiatric Hospital

Aalborg, 9000, Denmark

Location

Related Publications (2)

  • Nielsen J, Emborg C, Gydesen S, Dybbro J, Aagaard J, Haderup K, Glyngdal P, Fabricius S, Thode D, Lublin H, Andersen T, Damkier P, Taylor D. Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study. J Clin Psychopharmacol. 2012 Apr;32(2):173-8. doi: 10.1097/JCP.0b013e318248dfb8.

    PMID: 22367659DERIVED

  • Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Acta Psychiatr Scand. 2012 Jul;126(1):31-9. doi: 10.1111/j.1600-0447.2012.01840.x. Epub 2012 Feb 22.

    PMID: 22356584DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

sertindole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jimmi Nielsen, M.D.

    Aalborg Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

DK(1)