Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen
|ClinicalTrials.gov Identifier: NCT01555814|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment|
|Schizophrenia Schizophreniform Disorder Schizoaffective Disorder||Drug: Amisulpride|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): the Effects of D2 Antagonism on Candidate Endophenotypes|
|Study Start Date :||May 2011|
|Primary Completion Date :||July 2016|
|Study Completion Date :||October 2016|
For 4 weeks, all patients will be treated with amisulpride open label.
4-week open label amisulpride treatment
Other Name: Solian
- 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.
- 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.
- 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
- 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.
- 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.
- Change in processing speed over time after antipsychotic treatment. [ Time Frame: Baseline, 4 weeks, 6,12,24 months ]Processing speed is expected to improve.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555814
|Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark|
|Principal Investigator:||Birte Glenthøj, MD, DMSc||Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Glostrup, Denmark|