Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.
NCT ID: NCT07047651
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2025-06-04
2027-12-20
Brief Summary
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Detailed Description
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Treatment resistant schizophrenia and treatment resistant bipolar disorder are the most difficult chronic mental health disorders which need long-term treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
Pharmacotherapy and RECOVERYTRSGR 20 participants
Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram), 20 people
A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) with RECOVERYTRSGR (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions.
Group B
Pharmacotherapy and TAU. 15 participants
Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants, 15 people
The combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) and TAU (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions. The control group of Group A
Group C
Pharmacotherapy and RECOVERYTRSBDGR. 15 participants
Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine
A combination of pharmacotherapy with RECOVERYTRSBDGR (antipsychotics, anxiolytics, antidepressants, mood stabilizers) for patients with treatment-resistant bipolar disorder. 140 sessions, 15 people
Group D
Pharmacotherapy and TAU. 10 participants
Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)
A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants, mood stabilizers) and TAU (psychotherapy). A control group to RECOVERYTRSBDGR. 140 sessions. 10 people
Interventions
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Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram), 20 people
A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) with RECOVERYTRSGR (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions.
Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants, 15 people
The combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) and TAU (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions. The control group of Group A
Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine
A combination of pharmacotherapy with RECOVERYTRSBDGR (antipsychotics, anxiolytics, antidepressants, mood stabilizers) for patients with treatment-resistant bipolar disorder. 140 sessions, 15 people
Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)
A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants, mood stabilizers) and TAU (psychotherapy). A control group to RECOVERYTRSBDGR. 140 sessions. 10 people
Eligibility Criteria
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Inclusion Criteria
* IQ ≥ 80
* Diagnosis TRS.
* age 18-65
* IQ ≥ 80
* Diagnosis TRSBD.
Exclusion Criteria
* Relapse and hospitalization.
* Substance abuse and head injuries. If substance abuse is successfully treated, the participant will be acknowledged into our program.
* Relapse and hospitalization.
18 Years
65 Years
ALL
No
Sponsors
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Dr. Stavroula Rakitzi
OTHER
Responsible Party
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Dr. Stavroula Rakitzi
Director
Principal Investigators
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Dr. Stavroula Rakitzi, PhD
Role: STUDY_DIRECTOR
Private Practice
Dr. Polyxeni Georgila, M. D.
Role: STUDY_DIRECTOR
Private Practice
Locations
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Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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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.
2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.
3. Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag.
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
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.
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.
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.
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.
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.
10. Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). The Greek version.
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.
12. Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: Parisianos.
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
14. Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: Scientific Publications.
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.
16. Nuechterlein, K.H., & Green, M.F. (2006). Matrics Consensus Cognitive Battery. MATRICS. Los Angeles: MATRICS Assessment Inc.
17. Rakitzi, S., & Georgila, P. (2024). Treatment resistant schizophrenia. Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and rehabilitation. Springer.
18. Rakitzi, S., & Georgila, P. (2024b). Treatment resistant bipolar disorder. Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and rehabilitation. Springer.
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.
20. World Health Organization. International classification of functioning, disability and health (ICF). Geneva: World Health Organization; 2001.
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
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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RAKITZI & GEORGILA RECOVERY
Identifier Type: -
Identifier Source: org_study_id
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