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NCT Number: NCT01555814

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Glostrup Municipality, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amisulpride

Drug

4-week open label amisulpride treatment

Other names: Solian

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Change in processing speed over time after antipsychotic treatment.

    Time frame: Baseline, 4 weeks, 6,12,24 months

    Processing speed is expected to improve.

  6. 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.

Sponsors and collaborators

Lead sponsor

Birte Glenthoj

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2012
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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