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

May 25, 2016 updated by: Birte Glenthoj, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, DK-2600
        • Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Solian
Active Comparator: second choice treatment
treatment with aripiprazole
Drug: aripiprazole
Individually dosed, according to symptoms, for a period of 6 weeks
Other Names:
  • abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship between specific neuropsychiatric measures and improvement on PANSS scores
Time Frame: 6 weeks of medical treatment
6 weeks of medical treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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,
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
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
6 weeks of medical treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

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

Investigators

  • Study Director: Birte Y Glenthoj, professor, University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2008-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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