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Completed

NCT Number: NCT01154829

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Glostrup Municipality, DK-2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Amisulpride

Drug

Individually dosed, according to symptoms, for a period of 6 weeks

Other names: Solian

Aripiprazole

Drug

Individually dosed, according to symptoms, for a period of 6 weeks

Other names: abilify

Primary outcomes

  1. Relationship between specific neuropsychiatric measures and improvement on PANSS scores

    Time frame: 6 weeks of medical treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PECANS

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Jul 1, 2010
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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