MedDataX Logo

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

NCT ID: NCT01555814

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizophreniform Disorder Schizoaffective Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amisulpride

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

Group Type EXPERIMENTAL

Amisulpride

Intervention Type DRUG

4-week open label amisulpride treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amisulpride

4-week open label amisulpride treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Solian

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Institute of Psychiatry, London

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

Copenhagen Hospital Corporation

OTHER

Sponsor Role collaborator

Birte Glenthoj

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Birte Glenthoj

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Birte Glenthøj, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Glostrup Municipality, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Related Links

Access external resources that provide additional context or updates about the study.

http://cnsr.dk

Site home page

http://www.cinsr.dk

Site home page

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-1-2010-142

Identifier Type: -

Identifier Source: org_study_id