Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.

The Effectiveness and Efficacy of the Combination of Pharmacotherapy With the Two New Recovery-oriented Programs, RECOVERYTRSGR (Treatment Resistant Schizophrenia) and RECOVERYTRSBDGR (Treatment Resistant Bipolar Disorder)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07047651

Acronym

RAKGEORREC

Enrollment

Registered

2025-07-02

Start date

2025-06-04

Completion date

2027-12-20

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Bipolar Disorder, Treatment Resistant Schizophrenia

Keywords

RECOVERYTRSGR, RECOVERYTRSBDGR, Treatment resistant schizophrenia, Treatment resistant bipolar disorder, Recovery-oriented therapy

Brief 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.

Detailed description

RECOVERYTRSGR is a newly developed program for patients with treatment resistant schizophrenia by Dr. S. Rakitzi and Dr. P. Georgila. RECOVERYTRSBDGR is a newly developed program for patients with treatment resistant bipolar disorder by Dr. S. Rakitzi and Dr. P. Georgila. These programs offer a long term combination of pharmacotherapy and cognitive behavioral psychotherapy and rehabilitation and aim to imrove cognition, symptoms, functional outcomes and recovery. Treatment resistant schizophrenia and treatment resistant bipolar disorder are the most difficult chronic mental health disorders which need long-term treatment.

Interventions

COMBINATION_PRODUCTGroup A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram),

A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) with RECOVERYTRSGR (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions. 22 patients

COMBINATION_PRODUCTGroup B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants,

The combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) and TAU (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions. The control group of Group A 20 patients

COMBINATION_PRODUCTGroup 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, 22 people

COMBINATION_PRODUCTGroup 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. 20 people

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Pharmacotherapy and RECOVERYTRSGR (190 sessions) will be compared to treatment as usual (TAU) and pharmacotherapy (190 sessions) and Pharmacotherapy and RECOVERYTRSBDGR (140 sessions) will be compared also to TAU and pharmacotherapy (140 sessions).

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

For patients with treatment resistant schizophrenia: * age 18-65 * IQ ≥ 80 * Diagnosis TRS. Inclusion criteria for patients with treatment resistant bipolar disorder: * age 18-65 * IQ ≥ 80 * Diagnosis TRSBD.

Exclusion criteria

For patients with treatment resistant schizophrenia: * Substance abuse and head injury. If substance abuse is successfully treated, the participant will be accepted into our program. * Relapse and hospitalization.

Design outcomes

Primary

Measure	Time frame	Description
MCCB BACS symbol coding (for RECOVERYTRSGR)	Pre-intervention	It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)	Pre-intervention	It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)	Pre-intervention	It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Brief visuospatial memory test (for RECOVERYTRSGR)	Pre-intervention	It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)	Pre-intervention	It measures social cognition. Minimum 0, maximum 67. high scores better.
Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)	Pre-intervention	It measures social cognition. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Title (for RECOVERYTRSGR)	Pre-intervention	It measures social cognition. Minimum 0, maximum 12. high scores better.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)	Pre-intervention	It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)	Pre-intervention	It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
PANNS total (for RECOVERYTRSGR)	Pre-intervention	It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
WHODAS total (for RECOVERYTRSGR)	Pre-intervention	It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total (for RECOVERYTRSGR)	Pre-intervention	It measures recovery. Minimum 0, maximum 152. High scores better.
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)	Pre-intervention	It measures severity of illness. Minimum 0, Maximum 7, low scores better.
SRSDA (for RECOVERYTRSBDGR)	Pre-intervention	It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
Hamilton Depression Scale (for RECOVERYTRSBDGR)	Pre-intervention	It measures depression. Minimum 0, maximum 23. Low scores better.
Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)	Pre-intervention	It measures depression. Minimum 0, maximum 60. Low scores better.
The Altman self-rating scale (for RECOVERYTRSBDGR)	Pre-intervention	It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
PSYRAT (for RECOVERYTRSBDGR)	Pre-intervention	It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 44. Low scores better.
WHODAS total (for RECOVERYTRSBDGR)	Pre-intervention	It measures functional outcome. Minimum 0, maximum 100. Low scores better.
RAS-DS Total (for RECOVERYTRSBDGR)	Pre-intervention	It measures recovery. Minimum 0, maximum 152. High scores better
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)	Pre-intervention	It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Young mania rating scale (for RECOVERYTRSBDGR)	Pre-intervention	It measures mania. Minimum 0, maximum 60. Low scores better

Secondary

Measure	Time frame	Description
WAIS (for RECOVERYTRSGR)	Pre-intervention	It measures the Intelligenz-quotient
WAIS (for RECOVERYTRSBDGR)	Pre-intervention	It measures the Intelligenz-quotient

Countries

Greece

Contacts

STUDY_DIRECTORDr. Stavroula Rakitzi, PhD

Private Practice

STUDY_DIRECTORDr. Polyxeni Georgila, M. D.