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Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS) (PECANS)

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ClinicalTrials.gov Identifier: NCT01154829
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : May 26, 2016
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Institute of Psychiatry, London
UMC Utrecht
Copenhagen Hospital Corporation
Information provided by (Responsible Party):
Birte Glenthoj, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE June 21, 2010
First Posted Date  ICMJE July 1, 2010
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
Relationship between specific neuropsychiatric measures and improvement on PANSS scores [ Time Frame: 6 weeks of medical treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
Global improvement on PANSS scores after D2 antagonism [ Time Frame: 6 weeks of medical treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
  • The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 blockade [ Time Frame: Baseline, 6 weeks ]
  • Time/dose improvement on PPI and other psychophysiological measures of early information processing after D2 blockade [ Time Frame: Baseline, 2 and 6 weeks, 6,12,24 months ]
  • Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients [ Time Frame: Baseline and 6 weeks follow up ]
  • Structural changes in grey and white matter before and after D2 blockade [ Time Frame: 6 weeks, 6, 12 and 24 months, ]
  • Cognitive differences at baseline and changes over time after D2 blockade [ Time Frame: Baseline, 6 weeks, 6,12,24 months ]
  • The effect of D2 blockade on reward related fMRI BOLD response [ Time Frame: 6 weeks of medical treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
  • The relation between D2 binding potentiel (SPECT) and reward related brain avtivity (fMRI BOLD response) before and after D2 antagonism [ Time Frame: Baseline, 6 weeks ]
  • Time/dose improvement on P50 supression after antipsychotic treatment [ Time Frame: Baseline, 2 and 6 weeks, 6,12,24 months ]
  • Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients [ Time Frame: Baseline ]
  • Hippocampal loss and basal ganglia increase after antipsychotic treatment [ Time Frame: 6 weeks, 6, 12 and 24 months, ]
  • Processing speed improvement over time after antipsychotic treatment [ Time Frame: Baseline, 6 weeks, 6,12,24 months ]
  • The effect of D2 blockade on reward related fMRI BOLD response [ Time Frame: 6 weeks of medical treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)
Official Title  ICMJE Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: amisulpride
    Individually dosed, according to symptoms, for a period of 6 weeks
    Other Name: Solian
  • Drug: aripiprazole
    Individually dosed, according to symptoms, for a period of 6 weeks
    Other Name: abilify
Study Arms  ICMJE
  • Active Comparator: first choice treatment
    Treatment with amisulpride
    Intervention: Drug: amisulpride
  • Active Comparator: second choice treatment
    treatment with aripiprazole
    Intervention: Drug: aripiprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
136
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2010)
120
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154829
Other Study ID Numbers  ICMJE H-D-2008-088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Birte Glenthoj, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • Glostrup University Hospital, Copenhagen
  • Rigshospitalet, Denmark
  • Institute of Psychiatry, London
  • UMC Utrecht
  • Copenhagen Hospital Corporation
Investigators  ICMJE
Study Director: Birte Y Glenthoj, professor University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
PRS Account University of Copenhagen
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP