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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: amisulpride Drug: aripiprazole Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes
Study Start Date : December 2008
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Relationship between specific neuropsychiatric measures and improvement on PANSS scores [ Time Frame: 6 weeks of medical treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients [ Time Frame: Baseline and 6 weeks follow up ]
  4. Structural changes in grey and white matter before and after D2 blockade [ Time Frame: 6 weeks, 6, 12 and 24 months, ]
  5. Cognitive differences at baseline and changes over time after D2 blockade [ Time Frame: Baseline, 6 weeks, 6,12,24 months ]
  6. The effect of D2 blockade on reward related fMRI BOLD response [ Time Frame: 6 weeks of medical treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154829


Locations
Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup, Denmark, DK-2600
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
homepage of the research unit  This link exits the ClinicalTrials.gov site
homepage of the research unit  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Birte Glenthoj, professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01154829     History of Changes
Other Study ID Numbers: H-D-2008-088
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Aripiprazole
Sultopride
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action