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

Arm | Intervention/treatment |
---|---|
Active Comparator: first choice treatment
Treatment with amisulpride
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Drug: amisulpride
Individually dosed, according to symptoms, for a period of 6 weeks
Other Name: Solian |
Active Comparator: second choice treatment
treatment with aripiprazole
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Drug: aripiprazole
Individually dosed, according to symptoms, for a period of 6 weeks
Other Name: abilify |
- Relationship between specific neuropsychiatric measures and improvement on PANSS scores [ Time Frame: 6 weeks of medical treatment ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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 -

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
Denmark | |
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | |
Glostrup, Denmark, DK-2600 |
Study Director: | Birte Y Glenthoj, professor | University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Birte Glenthoj, professor, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT01154829 |
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 |
dopamine first episode reward cognition MRI |
fMRI PPI P300 P50 gating endophenotypes |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Aripiprazole Amisulpride Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Dopamine Agonists |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists Antidepressive Agents, Second-Generation |