Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Copenhagen
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
ClinicalTrials.gov Identifier:
NCT01154829
First received: June 21, 2010
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Schizophrenia
Drug: amisulpride
Drug: aripiprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Relationship between specific neuropsychiatric measures and global improvement on PANSS scores [ Time Frame: 6 weeks of medical treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 antagonism [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
  • Time/dose improvement on P50 suppression after antipsychotic treatment [ Time Frame: Baseline, 2 and 6 weeks, 6,12,24 months ] [ Designated as safety issue: No ]
  • Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients [ Time Frame: Baseline and 6 weeks follow up ] [ Designated as safety issue: No ]
  • Hippocampal loss and basal ganglia increase after antipsychotic treatment [ Time Frame: 6 weeks, 6, 12 and 24 months, ] [ Designated as safety issue: No ]
  • Processing speed improvement over time after antipsychotic treatment [ Time Frame: Baseline, 6 weeks, 6,12,24 months ] [ Designated as safety issue: No ]
  • The effect of D2 blockade on reward related fMRI BOLD response [ Time Frame: 6 weeks of medical treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: first choice treatment
Treatment with amisulpride
Drug: amisulpride
Individually dosed, according to symptoms, for a period of 6 weeks
Other Name: Solian
Active Comparator: second choice treatment
treatment with aripiprazole
Drug: aripiprazole
Individually dosed, according to symptoms, for a period of 6 weeks
Other Name: abilify

Detailed 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154829

Contacts
Contact: Birte Y Glenthoj, professor +45 43 23 34 31 birte.glenthoj@cnsr.dk

Locations
Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup Recruiting
Glostrup, Denmark, DK-2600
Contact: Birte Glenthoj, MD, DMSc.    +45 43 23 34 31    birte.glenthoj@cnsr.dk   
Principal Investigator: Birte Glenthoj, MD, DMSc         
Sub-Investigator: Mette O Nielsen, MD         
Sub-Investigator: Sanne Wulff, MD         
Sub-Investigator: Birgitte Fagerlund, PHD         
Sub-Investigator: Bob Oranje, PHD         
Sub-Investigator: Hans Rasmussen, PhD         
Sub-Investigator: Bjorn H Ebdrup, MD PhD         
Sub-Investigator: Maria H Larsen, M.Sc.         
Sponsors and Collaborators
University of Copenhagen
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Institute of Psychiatry, London
UMC Utrecht
Copenhagen Hospital Corporation
Investigators
Study Director: Birte Y Glenthoj, professor University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: Birte Glenthoj, professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01154829     History of Changes
Other Study ID Numbers: H-D-2008-088
Study First Received: June 21, 2010
Last Updated: December 19, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
dopamine
first episode
reward
cognition
MRI
fMRI
PPI
P300
P50 gating
endophenotypes

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Sultopride
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014