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Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

2014-08-27 03:12:30 | BioPortfolio

Summary

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.

Description

The study is designed as a 6 week case-control follow-up study of 60 AN FE pt. with SCZ and 60 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 Neuropsy-chiatry), medical and family history, and physical examination before inclusion. At baseline all 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 exam-ined with clinical validated rating scales to measure psychopathology, subjective well-being, and side-effects. After a period of 6 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 6 weeks. Based on this evaluation it will be decided to either continue the current (amisulpride) antipsychotic treatment, or to switch to aripiprazol. Efficacy of aripiprazol is evaluated on a monthly basis, if the patient does not respond well enough, than the treatment will be adapted individually. Regardelss of treatment, all subjects will be re-assessed in the same testbattery as mentioned above, except for SPECT and fMRI, after a period of 6, 12, and 24 months.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Schizophrenia

Intervention

amisulpride, olanzapin

Location

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup
Denmark
DK-2600

Status

Recruiting

Source

University of Copenhagen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:30-0400

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