AzTrials
AzTrials

Treatment Resistant SchizophreniaPhase 4RAKGEORRECNCT07047651

Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.

A Phase 4 study testing 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, and Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine in people with Treatment Resistant Schizophrenia and Treatment Resistant Bipolar Disorder, run by Dr. Stavroula Rakitzi at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
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, and Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteGreece
Study dates
4 Jun 2025to 20 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Exclusion criteria for patients with treatment resistant bipolar diosrder:

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

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

    Athens, 15771

Other trials in Greece

About this study

Official title: 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)

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.

Read the 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.

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, Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)
Keywords
RECOVERYTRSGR, RECOVERYTRSBDGR, Treatment resistant schizophrenia, Treatment resistant bipolar disorder, Recovery-oriented therapy
Medical subject headings
Schizophrenia, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

    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

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

    A combination of pharmacotherapy with RECOVERYTRSBDGR (antipsychotics, anxiolytics, antidepressants, mood stabilizers) for patients with treatment-resistant bipolar disorder. 140 sessions, 22 people

  • Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)Combination product

    A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants, mood stabilizers) and TAU (psychotherapy). A control group to RECOVERYTRSBDGR. 140 sessions. 20 people

Study groups in NCT07047651
Study groupRoleWhat they receive
Group AExperimentalPharmacotherapy and RECOVERYTRSGR 22 participants
Receives: Combination Product: Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram),
Group BActive comparatorPharmacotherapy and TAU. 20 participants
Receives: Combination Product: Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants,
Group CExperimentalPharmacotherapy and RECOVERYTRSBDGR. 22 participants
Receives: Combination Product: Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine
Group DActive comparatorPharmacotherapy and TAU. 20 participants
Receives: Combination Product: Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MCCB BACS symbol coding (for RECOVERYTRSGR)

    It measures speed of processing. Minimum 0, maximum 110, high scores better

    Measured: Pre-intervention

  2. MCCB BACS symbol coding (for RECOVERYTRSGR)

    It measures speed of processing. Minimum 0, maximum 110, high scores better

    Measured: Immediately after the intervention

  3. MCCB BACS symbol coding (for RECOVERYTRSGR)

    It measures speed of processing. Minimum 0, maximum 110, high scores better

    Measured: Follow-up up to 24 weeks

  4. MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)

    It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.

    Measured: Pre-intervention

  5. MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)

    It measures non-verbal working memory. Minimum 0, maximum 32, high scores better. Summary of forward and backward total score

    Measured: Immediately after the intervention

  6. MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)

    It measures non-verbal working memory. Minimum 0, maximum 32, high scores better. Summary of forward and backward total score

    Measured: Follow-up up to 24 weeks

  7. MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)

    It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better

    Measured: Pre-intervention

  8. MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)

    It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better

    Measured: Immediately after the intervention

  9. MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)

    It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better

    Measured: Follow-up up to 24 weeks

  10. MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

    It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.

    Measured: Pre-intervention

  11. MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

    It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.

    Measured: Immediately after the intervention

  12. MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

    It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.

    Measured: Follow-up up to 24 weeks

  13. Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 67. high scores better.

    Measured: Pre-intervention

  14. Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 67. high scores better.

    Measured: Immediately after the intervention

  15. Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 67. high scores better.

    Measured: Follow-up up to 24 weeks

  16. Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 12. high scores better.

    Measured: Pre-intervention

  17. Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 12. high scores better.

    Measured: Immediately after the intervention

  18. Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 12. high scores better.

    Measured: Follow-up up to 24 weeks

  19. Social Perception Scale (SPS) Title (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 12. high scores better.

    Measured: Pre-intervention

  20. Social Perception Scale (SPS) Title (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 12. high scores better.

    Measured: Immediately after the intervention

  21. Social Perception Scale (SPS) Title (for RECOVERYTRSGR)

    It measures social cognition. Minimum 0, maximum 12. high scores better.

    Measured: Follow-up up to 24 weeks

  22. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Pre-intervention

  23. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Pre-intervention

  24. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Immediately after the intervention

  25. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Immediately after the intervention

  26. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Follow-up up to 24 weeks

  27. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Follow-up up to 24 weeks

  28. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Pre-intervention

  29. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Pre-intervention

  30. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Immediately after the intervention

  31. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Immediately after the intervention

  32. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Follow-up up to 24 weeks

  33. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

    Measured: Follow-up up to 24 weeks

  34. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

    Measured: Pre-intervention

  35. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

    Measured: Pre-intervention

  36. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

    Measured: Immediately after the intervention

  37. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

    Measured: Immediately after the intervention

  38. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

    Measured: Follow-up up to 24 weeks

  39. The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

    Measured: Follow-up up to 24 weeks

  40. PANNS total (for RECOVERYTRSGR)

    It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better

    Measured: Pre-intervention

  41. PANNS total (for RECOVERYTRSGR)

    It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better

    Measured: Immediately after the intervention

  42. PANNS total (for RECOVERYTRSGR)

    It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better

    Measured: Follow-up up to 24 weeks

  43. WHODAS total (for RECOVERYTRSGR)

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

    Measured: Pre-intervention

  44. WHODAS total (for RECOVERYTRSGR)

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

    Measured: Immediately after the intervention

  45. WHODAS total (for RECOVERYTRSGR)

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

    Measured: Follow-up up to 24 weeks

  46. RAS-DS total (for RECOVERYTRSGR)

    It measures recovery. Minimum 0, maximum 152. High scores better.

    Measured: Pre-intervention

  47. RAS-DS total (for RECOVERYTRSGR)

    It measures recovery. Minimum 0, maximum 152. High scores better.

    Measured: Immediately after the intervention

  48. RAS-DS total (for RECOVERYTRSGR)

    It measures recovery. Minimum 0, maximum 152. High scores better.

    Measured: Follow-up up to 24 weeks

  49. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

    Measured: Pre-intervention

  50. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

    It. measures severity of illness. Minimum 0, Maximum 7, low scores better.

    Measured: Immediately after the intervention

  51. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

    It. measures severity of illness. Minimum 0, Maximum 7, low scores better.

    Measured: Follow-up up to 24 weeks

  52. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

    Measured: Pre-intervention

  53. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

    Measured: Immediately after the intervention

  54. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

    Measured: Follow-up up to 24 weeks

  55. SRSDA (for RECOVERYTRSBDGR)

    It measures Depression. Minimum 0, maximum 14 or higher. Low scores better

    Measured: Pre-intervention

  56. SRSDA (for RECOVERYTRSBDGR)

    It measures Depression. Minimum 0, maximum 14 or higher. Low scores better

    Measured: Immediately after the intervention

  57. SRSDA (for RECOVERYTRSBDGR)

    It measures Depression. Minimum 0, maximum 14 or higher. Low scores better

    Measured: Follow-up up to 24 weeks

  58. SRSDA (for RECOVERYTRSBDGR)

    It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better

    Measured: Pre-intervention

  59. SRSDA (for RECOVERYTRSBDGR)

    It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better

    Measured: Immediately after the intervention

  60. SRSDA (for RECOVERYTRSBDGR)

    It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better

    Measured: Follow-up up to 24 weeks

  61. Hamilton Depression Scale (for RECOVERYTRSBDGR)

    It measures depression. Minimum 0, maximum 23. Low scores better.

    Measured: Pre-intervention

  62. Hamilton Depression Scale (for RECOVERYTRSBDGR)

    It meaasures depression. Minimum 0, maximum 23. Low scores better.

    Measured: Immediately after the intervention

  63. Hamilton Depression Scale (for RECOVERYTRSBDGR)

    It meaasures depression. Minimum 0, maximum 23. Low scores better.

    Measured: Follow-up up to 24 weeks

  64. Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

    It measures depression. Minimum 0, maximum 60. Low scores better.

    Measured: Pre-intervention

  65. Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

    It measures depression. Minimum 0, maximum 60. Low scores better.

    Measured: Immediately after the intervention

  66. Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

    It measures depression. Minimum 0, maximum 60. Low scores better.

    Measured: Follow-up up to 24 weeks

  67. The Altman self-rating scale (for RECOVERYTRSBDGR)

    It measures mania. Minimum 0, maximum 6 or higher. Low scores better.

    Measured: Pre-intervention

  68. The Altman self-rating scale (for RECOVERYTRSBDGR)

    It measures mania. Minimum 0, maximum 6 or higher. Low scores better.

    Measured: Immediately after the intervention

  69. The Altman self-rating scale (for RECOVERYTRSBDGR)

    It measures mania. Minimum 0, maximum 6 or higher. Low scores better.

    Measured: Follow-up up to 24 weeks

  70. PSYRAT (for RECOVERYTRSBDGR)

    It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 44. Low scores better.

    Measured: Pre-intervention

  71. PSYRAT (for RECOVERYTRSBDGR)

    It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.

    Measured: Immediately after the intervention

  72. PSYRAT (for RECOVERYTRSBDGR)

    It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.

    Measured: Follow-up up to 24 weeks

  73. PSYRAT (for RECOVERYTRSBDGR)

    It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better.

    Measured: Pre-intervention

  74. PSYRAT (for RECOVERYTRSBDGR)

    It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better.

    Measured: Immediately after the intervention

  75. PSYRAT (for RECOVERYTRSBDGR)

    It measures psychotic symptoms. Delusions. Minimum 0, maximum 24. Low scores better.

    Measured: Follow-up up to 24 weeks

  76. WHODAS total (for RECOVERYTRSBDGR)

    It measures functional outcome. Minimum 0, maximum 100. Low scores better.

    Measured: Pre-intervention

  77. WHODAS total (for RECOVERYTRSBDGR)

    It measures functional outcome. Minimum 0, maximum 100. Low scores better.

    Measured: Immediately after the intervention

  78. WHODAS total (for RECOVERYTRSBDGR)

    It measures functional outcome. Minimum 0, maximum 100. Low scores better.

    Measured: Follow-up up to 24 weeks

  79. RAS-DS Total (for RECOVERYTRSBDGR)

    It measures recovery. Minimum 0, maximum 152. High scores better

    Measured: Pre-intervention

  80. RAS-DS Total (for RECOVERYTRSBDGR)

    It measures recovery. Minimum 0, maximum 152. High scores better

    Measured: Immediately after the intervention

  81. RAS-DS Total (for RECOVERYTRSBDGR)

    It measures recovery. Minimum 0, maximum 152. High scores better

    Measured: Follow-up up to 24 weeks

  82. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

    Measured: Pre-intervention

  83. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

    Measured: Immediately after the intervention

  84. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

    Measured: Follow-up up to 24 weeks

  85. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

    Measured: Pre-intervention

  86. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

    Measured: Immediately after the intervention

  87. The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

    Measured: Follow-up up to 24 weeks

  88. The Young mania rating scale (for RECOVERYTRSBDGR)

    It measures mania. Minimum 0, maximum 60. Low scores better

    Measured: Pre-intervention

  89. The Young mania rating scale (for RECOVERYTRSBDGR)

    It measures mania. Minimum 0, maximum 60. Low scores better

    Measured: Immediately after the intervention

  90. The Young mania rating scale (for RECOVERYTRSBDGR)

    It measures mania. Minimum 0, maximum 60. Low scores better

    Measured: Follow-up up to 24 weeks

Secondary outcomes (2)

  1. WAIS (for RECOVERYTRSGR)

    It measures the Intelligenz-quotient

    Measured: Pre-intervention

  2. WAIS (for RECOVERYTRSBDGR)

    It measures the Intelligenz-quotient

    Measured: Pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start4 Jun 2025
  3. Primary completion20 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047651
Sponsor's protocol ID
RAKITZI & GEORGILA RECOVERY
Acronym
RAKGEORREC
Status last verified
Apr 2026
First submitted
11 Apr 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is the first study regarding the efficacy and effectiveness of RECOVERYTRSGR, and RECOVERYTRSBDGR, which are developed by us.

Publications

  • 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.

    PubMed 9359982

  • 2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 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, and Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine in people with Treatment Resistant Schizophrenia and Treatment Resistant Bipolar Disorder, run by Dr. Stavroula Rakitzi at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MCCB BACS symbol coding (for RECOVERYTRSGR) (time frame: Pre-intervention). The study lists 90 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07047651, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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