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The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

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ClinicalTrials.gov Identifier: NCT02021201
Recruitment Status : Terminated (No suitable patients could be recruited in the available time period)
First Posted : December 27, 2013
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Birte Glenthoj, University of Copenhagen

Study Description
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Brief Summary:
This comparison is made between the effects of sertindole and risperidone on vulnerability indicators in schizophrenia. More specifically: the effects of these two antipsychotic compounds on basic processing of incoming information is studied. The investigators expect that the newer antipsychotic sertindole to be more effective in restoring information processing in schizophrenia patients than risperidone.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: risperidone Drug: Sertindole Phase 4

Detailed Description:
The study is has a so-called double blind, randomized - yet balanced - cross-over design, in which 24 male patients with schizophrenia are included. After inclusion in the study, patients will be assessed in a test-battery, in which psychophysiological parameters of their basic information capabilities are quantified. Following this, the patients will be treated with either risperidone or sertindole for a period of 10 weeks, after which they will cross-over to the other treatment (the order of treatments is randomized (and balanced)). The battery of tests is repeated after the first and second treatment period. In addition, a second test-battery will be performed at these follow-up intervals, to assess neuropsychological parameters of information processing. To evaluate the extend of the treatment effects, the patients will be matched (age, gender, parental socioeconomic status) to 24 healthy controls.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia, a Comparative Study
Study Start Date : July 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound
 Drug: risperidone
Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
Other Name: Risperdal

Drug: Sertindole
Patients with schizophrenia will be treated for 10 weeks treatment with serindole
Other Name: Serdolect
Experimental: 2
Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound
 Drug: risperidone
Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
Other Name: Risperdal

Drug: Sertindole
Patients with schizophrenia will be treated for 10 weeks treatment with serindole
Other Name: Serdolect


Outcome Measures
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Primary Outcome Measures :
  1. Psychophysiological parameters sensory gating [ Time Frame: baseline, after ten weeks and after 20 weeks ]

Secondary Outcome Measures :
  1. Psychophysiological parameters of selective attention [ Time Frame: Baseline, 10 weeks and 20 weeks after treatment ]
  2. Neurocognitive parameters of amongst others executive functioning, attention, and reaction time [ Time Frame: 10 weeks and 20 weeks after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy controls:

  • matched by age (+/- 2 years), gender and parental socioeconomic status to patients with schizophrenia.
  • age between 18-55 years
  • male
  • physically and mentally healthy and no daily intake of medicine
  • no current substance abuse

Patients:

  • patients who fulfill both ICD-10 and DSM IV diagnostic criteria for schizophrenia.
  • age between 18-55 years
  • male
  • patients who need a change in their medication
  • diagnosed with schizophrenia within the last 10 years
  • not formerly treated with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
  • physically healthy
  • no current substance abuse

Exclusion Criteria:

Controls:

  • a history of mental illness in the first degree relatives
  • hearing disabilities
  • head injury accompanied by unconsciousness for more than 5 min.
  • physical illness with a need of daily intake of medicine
  • positive screening for drugs of abuse at baseline.

Patients:

  • head injury accompanied by unconsciousness for more than 5 min.
  • serious medical conditions (more specific: brain diseases and diseases which cause a daily intake of medicine, heart, liver or kidney diseases, diabetes and prolongation of the QTc-interval (or a family history of such) and patients with phenylketonuri)
  • abuse of alcohol or medication/ narcotics during the last 6 months or positive screening for drugs of abuse at baseline.
  • former treatment with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
  • hearing disability
  • allergy towards the content in the medicine used in the study
  • bradycardia (pulse under 50 beats per minute) and QTc>450 ms
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021201


Locations
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Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Birte Glenthoj
Icahn School of Medicine at Mount Sinai
Investigators
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Study Director: Birte Y Glenthoj, PhD Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Principal Investigator: Bob Oranje, PhD Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Principal Investigator: Birgitte Fagerlund, PhD Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Principal Investigator: Rita S Godske, MD Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
More Information
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Additional Information:

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Responsible Party: Birte Glenthoj, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02021201    
Other Study ID Numbers: H-A-2008-062
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Sertindole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents