Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen
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|ClinicalTrials.gov Identifier: NCT01555814|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizophreniform Disorder Schizoaffective Disorder||Drug: Amisulpride||Not Applicable|
|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|
|Actual Primary Completion Date :||July 2016|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|