drugset / Trial / NCT02339844
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.
Timeline
- Start
- 2014-01
- Primary completion
- 2021-01
- Completion
- 2021-01
Publications
- Bojesen KB, Ambrosen KS, Sigvard AK, Nielsen MO, Gjedde A, Kumakura Y, Jensen LT, Fuglo D, Ebdrup BH, Rostrup E, Glenthoj BY. Interrelations between dopaminergic-, gabaergic- and glutamatergic neurotransmitters in antipsychotic-naive psychosis patients and the association to initial treatment response. Mol Psychiatry. 2026 Mar;31(3):1231-1240. doi: 10.1038/s41380-025-03229-0. Epub 2025 Sep 12.
- Bojesen KB, Broberg BV, Fagerlund B, Jessen K, Thomas MB, Sigvard A, Tangmose K, Nielsen MO, Andersen GS, Larsson HBW, Edden RAE, Rostrup E, Glenthoj BY. Associations Between Cognitive Function and Levels of Glutamatergic Metabolites and Gamma-Aminobutyric Acid in Antipsychotic-Naive Patients With Schizophrenia or Psychosis. Biol Psychiatry. 2021 Feb 1;89(3):278-287. doi: 10.1016/j.biopsych.2020.06.027. Epub 2020 Jul 10.
- Jessen K, Mandl RCW, Fagerlund B, Bojesen KB, Raghava JM, Obaid HG, Jensen MB, Johansen LB, Nielsen MO, Pantelis C, Rostrup E, Glenthoj BY, Ebdrup BH. Patterns of Cortical Structures and Cognition in Antipsychotic-Naive Patients With First-Episode Schizophrenia: A Partial Least Squares Correlation Analysis. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 May;4(5):444-453. doi: 10.1016/j.bpsc.2018.09.006. Epub 2018 Sep 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | — | — |