drugset / Trial / NCT07047651
Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.
RandomizedParallel-groupSingle-blindTreatment
Summary
The effectiveness and efficacy of the combination of pharmacotherapy with the two new recovery-oriented programs, RECOVERYTRSGR for patients with treatment- resistant schizophrenia and RECOVERYTRSBDGR for patients with treatment- resistant bipolar disorder.
Timeline
- Start
- 2025-06-04
- Primary completion
- 2027-12-20
- Completion
- 2027-12-20
Publications
- Background Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman Self-Rating Mania Scale. Biol Psychiatry. 1997 Nov 15;42(10):948-55. doi: 10.1016/S0006-3223(96)00548-3.
- Background 2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.
- Background 3. Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag.
- Background Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background 5. Donias, S., Karastergiou, A., & Manos N. (1991). Standardization of the symptom checklist-90-R rating scale in a Greek population. Psychiatriki, 2(1), 42-48.
- Background Fountoulakis KN, Iacovides A, Kleanthous S, Samolis S, Gougoulias K, St Kaprinis G, Bech P. The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study. BMC Psychiatry. 2003 Dec 10;3:21. doi: 10.1186/1471-244X-3-21.
- Background 7. Guy, W. (ed). (1976). ECDEU Assessment. Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976.
- Background Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.
- Background 9. Hancock, N., Scanlan, J.N., Bundy, A.C., Honey, A. (2019). Recovery Assessment Scale -Domains & Stages (RAS-DS) Manual- Version 3. Sydney: University of Sydney.
- Background 10. Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). The Greek version.
- Background Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
- Background 12. Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: Parisianos.
- Background 13. Koumpouros, Y., Papageorgiou, E., & Sakellari E. et al. (2018). Adaptation and psychometric properties evaluation of the Greek version of WHODAS 2.0. Pilot application in Greek elderly population. Health Services and Outcomes Research Methodology, 18(1), 63-74. https://doi.org/10.1007/s10742-017-0176-x
- Background 14. Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: Scientific Publications.
- Background Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
- Background 16. Nuechterlein, K.H., & Green, M.F. (2006). Matrics Consensus Cognitive Battery. MATRICS. Los Angeles: MATRICS Assessment Inc.
- Background 17. Rakitzi, S., & Georgila, P. (2024). Treatment resistant schizophrenia. Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and rehabilitation. Springer.
- Background 18. Rakitzi, S., & Georgila, P. (2024b). Treatment resistant bipolar disorder. Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and rehabilitation. Springer.
- Background Williams JB, Kobak KA. Development and reliability of a structured interview guide for the Montgomery Asberg Depression Rating Scale (SIGMA). Br J Psychiatry. 2008 Jan;192(1):52-8. doi: 10.1192/bjp.bp.106.032532.
- Background 20. World Health Organization. International classification of functioning, disability and health (ICF). Geneva: World Health Organization; 2001.
- Background Fuentes, I., Garcia, S., Ruiz, J.C., Soler, J., & Roder, V. (2007). Social perception scale in Schizophrenia. A pilot study. International Journal of Psychology and Psychological therapy, 7 (1), 1-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Aripiprazole | Other / unclassified | — | — |
| Background | Asenapine | Other / unclassified | — | — |
| Background | Citalopram | Small molecule | — | — |
| Background | Clonazepam | Small molecule | — | — |
| Background | Clozapine | Other / unclassified | — | — |
| Background | Lithium | Unknown | — | — |
| Background | Olanzapine | Small molecule | — | — |
| Background | Paliperidone | Unknown | — | — |
| Background | Risperidone | Other / unclassified | — | — |
| Background | Tavor | Unknown | — | — |
| Background | Valproic Acid | Small molecule | — | — |
| Background | Zuclopenthixol | Unknown | — | — |
| Background | quietiapine | Unknown | — | — |
| Background | stedon | Unknown | — | — |
| Background | zyprasidone | Unknown | — | — |