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NCT Number: NCT07047651

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 for patients with treatment- resistant schizophrenia and RECOVERYTRSBDGR for patients with treatment- resistant bipolar disorder.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Treatment Resistant Schizophrenia Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Treatment Resistant Bipolar Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Athens, 15771, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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, depakine

Combination 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

Primary outcomes

  1. MCCB BACS symbol coding (for RECOVERYTRSGR)

    Time frame: Pre-intervention

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

  2. MCCB BACS symbol coding (for RECOVERYTRSGR)

    Time frame: Immediately after the intervention

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

  3. MCCB BACS symbol coding (for RECOVERYTRSGR)

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

  10. MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

    Time frame: Pre-intervention

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

  11. MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

    Time frame: Immediately after the intervention

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

  12. MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Follow-up up to 24 weeks

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

  40. PANNS total (for RECOVERYTRSGR)

    Time frame: Pre-intervention

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

  41. PANNS total (for RECOVERYTRSGR)

    Time frame: Immediately after the intervention

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

  42. PANNS total (for RECOVERYTRSGR)

    Time frame: Follow-up up to 24 weeks

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

  43. WHODAS total (for RECOVERYTRSGR)

    Time frame: Pre-intervention

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

  44. WHODAS total (for RECOVERYTRSGR)

    Time frame: Immediately after the intervention

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

  45. WHODAS total (for RECOVERYTRSGR)

    Time frame: Follow-up up to 24 weeks

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

  46. RAS-DS total (for RECOVERYTRSGR)

    Time frame: Pre-intervention

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

  47. RAS-DS total (for RECOVERYTRSGR)

    Time frame: Immediately after the intervention

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

  48. RAS-DS total (for RECOVERYTRSGR)

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

  55. SRSDA (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  56. SRSDA (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  57. SRSDA (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

  58. SRSDA (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  59. SRSDA (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  60. SRSDA (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

  61. Hamilton Depression Scale (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  62. Hamilton Depression Scale (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  63. Hamilton Depression Scale (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

  64. Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  65. Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  66. Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

  70. PSYRAT (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  71. PSYRAT (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  72. PSYRAT (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

  73. PSYRAT (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  74. PSYRAT (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  75. PSYRAT (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

  76. WHODAS total (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  77. WHODAS total (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  78. WHODAS total (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

  79. RAS-DS Total (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  80. RAS-DS Total (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  81. RAS-DS Total (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

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

    Time frame: Pre-intervention

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

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

    Time frame: Immediately after the intervention

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

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

    Time frame: Follow-up up to 24 weeks

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

  88. The Young mania rating scale (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

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

  89. The Young mania rating scale (for RECOVERYTRSBDGR)

    Time frame: Immediately after the intervention

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

  90. The Young mania rating scale (for RECOVERYTRSBDGR)

    Time frame: Follow-up up to 24 weeks

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

Secondary outcomes

  1. WAIS (for RECOVERYTRSGR)

    Time frame: Pre-intervention

    It measures the Intelligenz-quotient

  2. WAIS (for RECOVERYTRSBDGR)

    Time frame: Pre-intervention

    It measures the Intelligenz-quotient

Sponsors and collaborators

Lead sponsor

Dr. Stavroula Rakitzi

Other

Registry information

Official study 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)

Acronym: RAKGEORREC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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