Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

Schizophrenia Clinical Trial

— PECANS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154829
• Other study ID #: H-D-2008-088
• Status: Completed
• Phase: N/A
• First received: June 21, 2010
• Last updated: May 25, 2016
• Start date: December 2008
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

For patients: meeting diagnostic criteria for schizophrenia according to ICD 10 or DSM IV antipsychotic naive The controls will be matched to the patients according to gender age and parental socio-economic status.

Exclusion Criteria:

Patients: mental retardation, other chronic diseases, use of antidepressive medicine during the last month,being pregnant, on going substance abuse

Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives,on going drug abuse, mental retardation -

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• amisulpride
Individually dosed, according to symptoms, for a period of 6 weeks
• aripiprazole
Individually dosed, according to symptoms, for a period of 6 weeks

Locations

Country	Name	City	State
Denmark	Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup	Glostrup

Sponsors (6)

Lead Sponsor	Collaborator
University of Copenhagen	Copenhagen Hospital Corporation, Glostrup University Hospital, Copenhagen, Institute of Psychiatry, London, Rigshospitalet, Denmark, UMC Utrecht

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between specific neuropsychiatric measures and improvement on PANSS scores		6 weeks of medical treatment	No
Secondary	The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 blockade		Baseline, 6 weeks	No
Secondary	Time/dose improvement on PPI and other psychophysiological measures of early information processing after D2 blockade		Baseline, 2 and 6 weeks, 6,12,24 months	No
Secondary	Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients		Baseline and 6 weeks follow up	No
Secondary	Structural changes in grey and white matter before and after D2 blockade		6 weeks, 6, 12 and 24 months,	No
Secondary	Cognitive differences at baseline and changes over time after D2 blockade		Baseline, 6 weeks, 6,12,24 months	No
Secondary	The effect of D2 blockade on reward related fMRI BOLD response		6 weeks of medical treatment	No

External Links

•   homepage of the research unit