Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen

October 25, 2016 updated by: Birte Glenthoj

Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): the Effects of D2 Antagonism on Candidate Endophenotypes

The investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) D2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, the investigators want to examine the influence of D2 receptor blockade on these disturbances. The investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments. The investigators do not expect any effect of treatment on brain structure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed as a 4 week case-control follow-up study of 90 FE pt. with SCZ and 90 controls matched with regard to age, gender, and parental socio-economic status. All subjects will be examined with a diagnostic interview (SCAN, Schedule for Clinical Assessment in Neuropsychiatry), medical and family history, and physical examination before inclusion. At baseline subjects will be examined with single photon emission computed tomography (SPECT), MRI, fMRI, psychophysiology, neurocognition. In addition, they will be screened for drugs, genetic testing, and ECG. Patients will further be examined with clinical validated rating scales to measure psychopathology, subjective well-being, and side-effects. After a period of 4 weeks all assessments are repeated. During that period patients will be treated with amisulpride, while healthy controls will receive no treatment at all. Efficacy of antipsychotic treatment will be evaluated after this initial period of 4 weeks. All subjects will be re-assessed in the same test battery as mentioned above, except for SPECT and fMRI, after a period of 6, 12, and 24 months.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark
        • Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV)
  • Age 18-40 years
  • Written informed consent.

Exclusion Criteria:

  • A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
  • Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime.
  • Intolerance to one of the drugs in this study. Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
  • Patients who are represented by a legal ward or under legal custody
  • The presence of one or more of the contraindications against any of the study drugs as mentioned in the SPC texts
  • Pregnancy, as determined through a pregnancy test, or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Amisulpride
For 4 weeks, all patients will be treated with amisulpride open label.
Drug: Amisulpride
4-week open label amisulpride treatment
Other Names:
  • Solian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between specific neuropsychiatric measures and global improvement on PANSS scores
Time Frame: 4 weeks of medical treatment
Changes in neuropsychiatric measures like (e.g. PPI, P50-suppression, neurocogtion etc.) will be evaluated and related to the primary outcome measure of the main OPTiMiSE study, the PANSS score change from baseline to follow-up.
4 weeks of medical treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of antipsychotic medication on the D2 binding potential (SPECT) in antipsychotic naive patients with schizophrenia.
Time Frame: Baseline, 4 weeks
D2 receptor binding will be evaluated at baseline and after 4 weeks of treatment. This will be related to measures of the human reward system.
Baseline, 4 weeks
Effect of antipsychotic medication on P50-suppression
Time Frame: Baseline, 4 weeks, 6,12,24 months
Time/dose improvement on P50 suppression after antipsychotic treatment
Baseline, 4 weeks, 6,12,24 months
Effect of antipsychotic medication on the human reward system
Time Frame: Baseline and 4 weeks follow up
Disturbances in the human reward system in antipsychotic naive patients with schizophrenia will be evaulated using a reward related BOLD fMRI paradigme.
Baseline and 4 weeks follow up
Change in hippocampal and basal ganglia volume from baseline to follow-up.
Time Frame: 4 weeks, 6, 12 and 24 months,
Hippocampal volume decrease and basal ganglia volume increase is expected longitudinal outcomes.
4 weeks, 6, 12 and 24 months,
Change in processing speed over time after antipsychotic treatment.
Time Frame: Baseline, 4 weeks, 6,12,24 months
Processing speed is expected to improve.
Baseline, 4 weeks, 6,12,24 months
Change in levels of brain perfusion from baseline to follow-up.
Time Frame: Baseline, 4 weeks treatment
Brain perfusion levels will be measured in brain areas related to the human reward systems.
Baseline, 4 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birte Glenthoj

Collaborators

Rigshospitalet, Denmark
UMC Utrecht
Glostrup University Hospital, Copenhagen
Copenhagen Hospital Corporation
Institute of Psychiatry, London

Investigators

  • Principal Investigator: Birte Glenthøj, MD, DMSc, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

March 14, 2012

First Posted (ESTIMATE)

March 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2010-142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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