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

NCT01555814 | Completed DMC

• 1 other identifier: H-1-2010-142
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

dopamine; first episode; reward; cognition; MRI; fMRI; PPI; P300; P50 gating; endophenotypes

Outcome Measures

Primary Outcomes (1)

• Relationship between specific neuropsychiatric measures and global improvement on PANSS scores

  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 Outcomes (6)

• Effect of antipsychotic medication on the D2 binding potential (SPECT) in antipsychotic naive patients with schizophrenia.

  Baseline, 4 weeks

• Effect of antipsychotic medication on P50-suppression

  Baseline, 4 weeks, 6,12,24 months

• Effect of antipsychotic medication on the human reward system

  Baseline and 4 weeks follow up

• Change in hippocampal and basal ganglia volume from baseline to follow-up.

  4 weeks, 6, 12 and 24 months,

• Change in processing speed over time after antipsychotic treatment.

  Baseline, 4 weeks, 6,12,24 months

Study Arms (1)

Amisulpride

EXPERIMENTAL

For 4 weeks, all patients will be treated with amisulpride open label.

Drug: Amisulpride

Interventions

Amisulpride DRUG

4-week open label amisulpride treatment

Also known as: Solian

Amisulpride

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birte Glenthoj: lead
• Glostrup University Hospital, Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator
• Institute of Psychiatry, London: collaborator
• UMC Utrecht: collaborator
• Copenhagen Hospital Corporation: collaborator

Study Sites (1)

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

Glostrup Municipality, Denmark

Location

Related Links

• Site home page
• Site home page

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Birte Glenthøj, MD, DMSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: March 15, 2012
• Study Start: May 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

DK (1)