Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07047651
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090663', 'term': 'Schizophrenia, Treatment-Resistant'}], 'ancestors': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003024', 'term': 'Clozapine'}, {'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D018967', 'term': 'Risperidone'}, {'id': 'C522667', 'term': 'asenapine'}, {'id': 'D000068882', 'term': 'Paliperidone Palmitate'}, {'id': 'D003006', 'term': 'Clopenthixol'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D002998', 'term': 'Clonazepam'}, {'id': 'C005419', 'term': 'oxybutynin'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D008094', 'term': 'Lithium'}, {'id': 'D014635', 'term': 'Valproic Acid'}, {'id': 'D015283', 'term': 'Citalopram'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D013892', 'term': 'Thioxanthenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014966', 'term': 'Xanthenes'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-01', 'size': 320303, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-18T04:04', 'hasProtocol': True}, {'date': '2025-06-01', 'size': 56340, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-18T04:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MCCB BACS symbol coding (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures speed of processing. Minimum 0, maximum 110, high scores better'}, {'measure': 'MCCB BACS symbol coding (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures speed of processing. Minimum 0, maximum 110, high scores better'}, {'measure': 'MCCB BACS symbol coding (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures speed of processing. Minimum 0, maximum 110, high scores better'}, {'measure': 'MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.'}, {'measure': 'MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures non-verbal working memory. Minimum 0, maximum 32, high scores better. Summary of forward and backward total score'}, {'measure': 'MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures non-verbal working memory. Minimum 0, maximum 32, high scores better. Summary of forward and backward total score'}, {'measure': 'MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better'}, {'measure': 'MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better'}, {'measure': 'MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better'}, {'measure': 'MCCB Brief visuospatial memory test (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.'}, {'measure': 'MCCB Brief visuospatial memory test (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.'}, {'measure': 'MCCB Brief visuospatial memory test (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures social cognition. Minimum 0, maximum 67. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures social cognition. Minimum 0, maximum 67. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures social cognition. Minimum 0, maximum 67. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures social cognition. Minimum 0, maximum 12. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures social cognition. Minimum 0, maximum 12. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures social cognition. Minimum 0, maximum 12. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Title (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures social cognition. Minimum 0, maximum 12. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Title (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures social cognition. Minimum 0, maximum 12. high scores better.'}, {'measure': 'Social Perception Scale (SPS) Title (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures social cognition. Minimum 0, maximum 12. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.'}, {'measure': 'The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.'}, {'measure': 'PANNS total (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better'}, {'measure': 'PANNS total (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better'}, {'measure': 'PANNS total (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better'}, {'measure': 'WHODAS total (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures functional outcome. Minimum 0, maximum 100. low scores better.'}, {'measure': 'WHODAS total (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures functional outcome. Minimum 0, maximum 100. low scores better.'}, {'measure': 'WHODAS total (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures functional outcome. Minimum 0, maximum 100. low scores better.'}, {'measure': 'RAS-DS total (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures recovery. Minimum 0, maximum 152. High scores better.'}, {'measure': 'RAS-DS total (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures recovery. Minimum 0, maximum 152. High scores better.'}, {'measure': 'RAS-DS total (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures recovery. Minimum 0, maximum 152. High scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures severity of illness. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It. measures severity of illness. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It. measures severity of illness. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures global improvement. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures global improvement. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures global improvement. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'SRSDA (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures Depression. Minimum 0, maximum 14 or higher. Low scores better'}, {'measure': 'SRSDA (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures Depression. Minimum 0, maximum 14 or higher. Low scores better'}, {'measure': 'SRSDA (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures Depression. Minimum 0, maximum 14 or higher. Low scores better'}, {'measure': 'SRSDA (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better'}, {'measure': 'SRSDA (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better'}, {'measure': 'SRSDA (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better'}, {'measure': 'Hamilton Depression Scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures depression. Minimum 0, maximum 23. Low scores better.'}, {'measure': 'Hamilton Depression Scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It meaasures depression. Minimum 0, maximum 23. Low scores better.'}, {'measure': 'Hamilton Depression Scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It meaasures depression. Minimum 0, maximum 23. Low scores better.'}, {'measure': 'Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures depression. Minimum 0, maximum 60. Low scores better.'}, {'measure': 'Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures depression. Minimum 0, maximum 60. Low scores better.'}, {'measure': 'Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures depression. Minimum 0, maximum 60. Low scores better.'}, {'measure': 'The Altman self-rating scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures mania. Minimum 0, maximum 6 or higher. Low scores better.'}, {'measure': 'The Altman self-rating scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures mania. Minimum 0, maximum 6 or higher. Low scores better.'}, {'measure': 'The Altman self-rating scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures mania. Minimum 0, maximum 6 or higher. Low scores better.'}, {'measure': 'PSYRAT (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 44. Low scores better.'}, {'measure': 'PSYRAT (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.'}, {'measure': 'PSYRAT (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.'}, {'measure': 'PSYRAT (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better.'}, {'measure': 'PSYRAT (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better.'}, {'measure': 'PSYRAT (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures psychotic symptoms. Delusions. Minimum 0, maximum 24. Low scores better.'}, {'measure': 'WHODAS total (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures functional outcome. Minimum 0, maximum 100. Low scores better.'}, {'measure': 'WHODAS total (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures functional outcome. Minimum 0, maximum 100. Low scores better.'}, {'measure': 'WHODAS total (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures functional outcome. Minimum 0, maximum 100. Low scores better.'}, {'measure': 'RAS-DS Total (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures recovery. Minimum 0, maximum 152. High scores better'}, {'measure': 'RAS-DS Total (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures recovery. Minimum 0, maximum 152. High scores better'}, {'measure': 'RAS-DS Total (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures recovery. Minimum 0, maximum 152. High scores better'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures severity of illness. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures severity of illness. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures severity of illness. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures global improvement. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures global improvement. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures global improvement. Minimum 0, Maximum 7, low scores better.'}, {'measure': 'The Young mania rating scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures mania. Minimum 0, maximum 60. Low scores better'}, {'measure': 'The Young mania rating scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Immediately after the intervention', 'description': 'It measures mania. Minimum 0, maximum 60. Low scores better'}, {'measure': 'The Young mania rating scale (for RECOVERYTRSBDGR)', 'timeFrame': 'Follow-up up to 24 weeks', 'description': 'It measures mania. Minimum 0, maximum 60. Low scores better'}], 'secondaryOutcomes': [{'measure': 'WAIS (for RECOVERYTRSGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures the Intelligenz-quotient'}, {'measure': 'WAIS (for RECOVERYTRSBDGR)', 'timeFrame': 'Pre-intervention', 'description': 'It measures the Intelligenz-quotient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RECOVERYTRSGR', 'RECOVERYTRSBDGR', 'Treatment resistant schizophrenia', 'Treatment resistant bipolar disorder', 'Recovery-oriented therapy'], 'conditions': ['Treatment Resistant Schizophrenia', 'Treatment Resistant Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '9359982', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.'}, {'type': 'BACKGROUND', 'citation': '3. Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag.'}, {'pmid': '20526405', 'type': 'BACKGROUND', 'citation': 'Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14667249', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10473315', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '10. Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). 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Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.'}, {'type': 'BACKGROUND', 'citation': '16. Nuechterlein, K.H., & Green, M.F. (2006). Matrics Consensus Cognitive Battery. MATRICS. Los Angeles: MATRICS Assessment Inc.'}, {'type': 'BACKGROUND', 'citation': '17. Rakitzi, S., & Georgila, P. (2024). Treatment resistant schizophrenia. Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and rehabilitation. Springer.'}, {'type': 'BACKGROUND', 'citation': '18. Rakitzi, S., & Georgila, P. (2024b). Treatment resistant bipolar disorder. Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and rehabilitation. Springer.'}, {'pmid': '18174510', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '20. World Health Organization. International classification of functioning, disability and health (ICF). Geneva: World Health Organization; 2001.'}, {'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTreatment resistant schizophrenia and treatment resistant bipolar disorder are the most difficult chronic mental health disorders which need long-term treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: For patients with treatment resistant schizophrenia:\n\n* age 18-65\n* IQ ≥ 80\n* Diagnosis TRS.\n\nInclusion criteria for patients with treatment resistant bipolar disorder:\n\n* age 18-65\n* IQ ≥ 80\n* Diagnosis TRSBD.\n\nExclusion Criteria: For patients with treatment resistant schizophrenia:\n\n* Substance abuse and head injury. If substance abuse is successfully treated, the participant will be accepted into our program.\n* Relapse and hospitalization.\n\nExclusion criteria for patients with treatment resistant bipolar diosrder:\n\n* Substance abuse and head injuries. If substance abuse is successfully treated, the participant will be acknowledged into our program.\n* Relapse and hospitalization.'}, 'identificationModule': {'nctId': 'NCT07047651', 'acronym': 'RAKGEORREC', 'briefTitle': 'Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.', 'organization': {'class': 'OTHER', 'fullName': 'Rakitzi, Stavroula'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'RAKITZI & GEORGILA RECOVERY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Pharmacotherapy and RECOVERYTRSGR 20 participants', 'interventionNames': ['Combination Product: Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram), 20 people']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Pharmacotherapy and TAU. 15 participants', 'interventionNames': ['Combination Product: Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants, 15 people']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Pharmacotherapy and RECOVERYTRSBDGR. 15 participants', 'interventionNames': ['Combination Product: Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Pharmacotherapy and TAU. 10 participants', 'interventionNames': ['Combination Product: Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)']}], 'interventions': [{'name': 'Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram), 20 people', 'type': 'COMBINATION_PRODUCT', 'description': 'A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) with RECOVERYTRSGR (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions.', 'armGroupLabels': ['Group A']}, {'name': 'Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants, 15 people', 'type': 'COMBINATION_PRODUCT', 'description': 'The combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants) and TAU (psychotherapy) for patients with treatment-resistant schizophrenia. 190 sessions. The control group of Group A', 'armGroupLabels': ['Group B']}, {'name': 'Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine', 'type': 'COMBINATION_PRODUCT', 'description': 'A combination of pharmacotherapy with RECOVERYTRSBDGR (antipsychotics, anxiolytics, antidepressants, mood stabilizers) for patients with treatment-resistant bipolar disorder. 140 sessions, 15 people', 'armGroupLabels': ['Group C']}, {'name': 'Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine)', 'type': 'COMBINATION_PRODUCT', 'description': 'A combination of pharmacotherapy (antipsychotics, anxiolytics, antidepressants, mood stabilizers) and TAU (psychotherapy). A control group to RECOVERYTRSBDGR. 140 sessions. 10 people', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15771', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Dr. Stavroula Rakitzi, PhD', 'role': 'CONTACT', 'email': 'Stavroula@Rakitzi.onmicrosoft.com', 'phone': '+306989766935'}, {'name': 'Polyxeni Georgila, M. D.', 'role': 'CONTACT', 'email': 'polyxenigeorgila@gmail.com', 'phone': '+306932905259'}, {'name': 'Stavroula Rakitzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Polyxeni Georgila, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Dr. Stavroula Rakitzi, PhD', 'role': 'CONTACT', 'email': 'Stavroula@Rakitzi.onmicrosoft.com', 'phone': '+306989766935'}, {'name': 'Dr. Polyxeni Georgila, M. D.', 'role': 'CONTACT', 'email': 'polyxenigeorgila@gmail.com', 'phone': '+306932905259'}], 'overallOfficials': [{'name': 'Dr. Stavroula Rakitzi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Private Practice'}, {'name': 'Dr. Polyxeni Georgila, M. D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Private Practice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is the first study regarding the efficacy and effectiveness of RECOVERYTRSGR, and RECOVERYTRSBDGR, which are developed by us.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Stavroula Rakitzi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dr. Stavroula Rakitzi', 'investigatorAffiliation': 'Rakitzi, Stavroula'}}}}