Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-23 @ 10:36 PM
Study NCT ID:
NCT01555814
Status:
None
Last Update Posted:
2016-10-26 00:00:00
First Post:
2011-09-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen
Sponsor:
None
Organization:
Study Overview
Official Title:
Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): the Effects of D2 Antagonism on Candidate Endophenotypes
Status:
None
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: