Recruiting

RAKGEORRECNew Pharmacotherapy Combined with RECOVERYTRSGR and RECOVERYTRSBDGR Programs for Treatment-Resistant Schizophrenia and Bipolar Disorder

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Study Aim

This clinical trial aims to evaluate the effectiveness of a new pharmacotherapy in combination with the RECOVERYTRSGR and RECOVERYTRSBDGR programs for treating adults with treatment-resistant schizophrenia or bipolar disorder, by measuring various cognitive and psychological symptoms.

What is being tested

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

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

+ Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine

Combination Product
Who is being recruted

Schizophrenia, Treatment-Resistant+1

+ Mental Disorders

+ Schizophrenia

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorDr. Stavroula Rakitzi
Study ContactDr. Stavroula Rakitzi, PhDMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 4, 2025

Actual date on which the first participant was enrolled.

This study focuses on improving treatment options for individuals with difficult-to-treat mental health conditions: treatment-resistant schizophrenia and treatment-resistant bipolar disorder. These are challenging conditions that require long-term care, and traditional treatments often do not provide enough relief. The study investigates the effectiveness of combining medication with two new programs, RECOVERYTRSGR for schizophrenia and RECOVERYTRSBDGR for bipolar disorder. These programs integrate medication, cognitive behavioral therapy, and rehabilitation to enhance mental recovery, improve cognitive functions, reduce symptoms, and improve daily functioning. Participants in this study undergo a combination of pharmacotherapy, which involves taking prescribed medication, and engaging in cognitive behavioral psychotherapy and rehabilitation. These interventions are designed to be long-term, providing ongoing support to help manage and potentially improve their condition. Although the study does not specify the exact outcomes measured, it aims to track improvements in cognition, symptom relief, and overall functional recovery. The study does not mention specific risks or side effects, but participants can potentially benefit from a comprehensive approach that targets multiple aspects of their mental health.

Official TitleThe 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)
NCT07047651
Principal SponsorDr. Stavroula Rakitzi
Study ContactDr. Stavroula Rakitzi, PhDMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Schizophrenia, Treatment-ResistantMental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

6 inclusion criteria required to participate
age 18-65

IQ ≥ 80

Diagnosis TRS

age 18-65

Show More Criteria

4 exclusion criteria prevent from participating
Substance abuse and head injury. If substance abuse is successfully treated, the participant will be accepted into our program.

Relapse and hospitalization.

Relapse and hospitalization.

Substance abuse and head injuries. If substance abuse is successfully treated, the participant will be acknowledged into our program.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Pharmacotherapy and RECOVERYTRSGR 22 participants

Group II

Active Comparator
Pharmacotherapy and TAU. 20 participants

Group III

Experimental
Pharmacotherapy and RECOVERYTRSBDGR. 22 participants

Group IV

Active Comparator
Pharmacotherapy and TAU. 20 participants

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE

Athens, GreeceOpen Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE in Google Maps
Recruiting
One Study Center