Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS) (PECANS)
This study has been completed.
Sponsor:
University of Copenhagen
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: May 25, 2016
Last verified: May 2016
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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.
| 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:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by University of Copenhagen:
Primary Outcome Measures:
- Relationship between specific neuropsychiatric measures and 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 blockade [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
- 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 ] [ 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 ]
- Structural changes in grey and white matter before and after D2 blockade [ Time Frame: 6 weeks, 6, 12 and 24 months, ] [ Designated as safety issue: No ]
- Cognitive differences at baseline and changes over time after D2 blockade [ 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 ]
| Enrollment: | 136 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2016 |
| Primary Completion Date: | May 2014 (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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| 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: | May 25, 2016 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Ethics Committee |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 23, 2016