NCT01154829

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is designed as a 6 week case-control follow-up study of 70 AN FE pt. with SCZ and 70 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 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 examined 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 aripiprazole. Efficacy of aripiprazole is evaluated on a monthly basis, if the patient does not respond well enough, than the treatment will be adapted individually. Regardless of treatment, 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. The developement in specific disturbances and the relationship between these will be analysed.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	amisulpride	Individually dosed, according to symptoms, for a period of 6 weeks
DRUG	aripiprazole	Individually dosed, according to symptoms, for a period of 6 weeks

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-05-01
• Completion: 2016-05-01
• First posted: 2010-07-01
• Last updated: 2016-05-26

Locations

1 site across 1 country: Denmark