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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): the Effects of D2 Antagonism on Candidate Endophenotypes|
- Relationship between specific neuropsychiatric measures and global improvement on PANSS scores [ Time Frame: 4 weeks of medical treatment ] [ Designated as safety issue: No ]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.
- Effect of antipsychotic medication on the D2 binding potential (SPECT) in antipsychotic naive patients with schizophrenia. [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]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.
- Effect of antipsychotic medication on P50-suppression [ Time Frame: Baseline, 4 weeks, 6,12,24 months ] [ Designated as safety issue: No ]Time/dose improvement on P50 suppression after antipsychotic treatment
- Effect of antipsychotic medication on the human reward system [ Time Frame: Baseline and 4 weeks follow up ] [ Designated as safety issue: No ]Disturbances in the human reward system in antipsychotic naive patients with schizophrenia will be evaulated using a reward related BOLD fMRI paradigme.
- Change in hippocampal and basal ganglia volume from baseline to follow-up. [ Time Frame: 4 weeks, 6, 12 and 24 months, ] [ Designated as safety issue: No ]Hippocampal volume decrease and basal ganglia volume increase is expected longitudinal outcomes.
- Change in processing speed over time after antipsychotic treatment. [ Time Frame: Baseline, 4 weeks, 6,12,24 months ] [ Designated as safety issue: No ]Processing speed is expected to improve.
- Change in levels of brain perfusion from baseline to follow-up. [ Time Frame: Baseline, 4 weeks treatment ] [ Designated as safety issue: No ]Brain perfusion levels will be measured in brain areas related to the human reward systems.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
For 4 weeks, all patients will be treated with amisulpride open label.
4-week open label amisulpride treatment
Other Name: Solian
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555814
|Contact: Birte Glenthøj, MD, DMSc||+45 43 23 34 firstname.lastname@example.org|
|Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark||Recruiting|
|Contact: Brian Broberg, MSc, PhD +45 386 40 553 email@example.com|
|Sub-Investigator: Signe Düring, MD|
|Sub-Investigator: Brian Broberg, MSc, PhD|
|Sub-Investigator: Sanne Wulff, MD|
|Sub-Investigator: Bob Oranje, PhD|
|Sub-Investigator: Birgitte Fagerlund, PhD|
|Principal Investigator: Birte Glenthøj, MD, DMSc|
|Sub-Investigator: Bjørn Ebdrup, MD, PhD|
|Principal Investigator:||Birte Glenthøj, MD, DMSc||Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark|