Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.

NCT07047651 | Active Not Recruiting Phase 4

• 1 other identifier: RAKITZI & GEORGILA RECOVERY
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The effectiveness and efficacy of the combination of pharmacotherapy with the two new recovery-oriented programs, RECOVERYTRSGR for patients with treatment- resistant schizophrenia and RECOVERYTRSBDGR for patients with treatment- resistant bipolar disorder.

Conditions

Treatment Resistant Bipolar Disorder; Treatment Resistant Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (90)

• MCCB BACS symbol coding (for RECOVERYTRSGR)

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

  Pre-intervention

• MCCB BACS symbol coding (for RECOVERYTRSGR)

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

  Immediately after the intervention

• MCCB BACS symbol coding (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• 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.

  Pre-intervention

• 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

  Immediately after the intervention

• 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

  Follow-up up to 24 weeks

• MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)

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

  Pre-intervention

• MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)

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

  Immediately after the intervention

• MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

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

  Pre-intervention

• MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

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

  Immediately after the intervention

• MCCB Brief visuospatial memory test (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)

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

  Pre-intervention

• Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)

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

  Immediately after the intervention

• Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)

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

  Pre-intervention

• Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)

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

  Immediately after the intervention

• Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• Social Perception Scale (SPS) Title (for RECOVERYTRSGR)

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

  Pre-intervention

• Social Perception Scale (SPS) Title (for RECOVERYTRSGR)

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

  Immediately after the intervention

• Social Perception Scale (SPS) Title (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• 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.

  Pre-intervention

• 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.

  Pre-intervention

• 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.

  Immediately after the intervention

• 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.

  Immediately after the intervention

• 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.

  Follow-up up to 24 weeks

• 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.

  Follow-up up to 24 weeks

• 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.

  Pre-intervention

• 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.

  Pre-intervention

• 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.

  Immediately after the intervention

• 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.

  Immediately after the intervention

• 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.

  Follow-up up to 24 weeks

• 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.

  Follow-up up to 24 weeks

• 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.

  Pre-intervention

• 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.

  Pre-intervention

• 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.

  Immediately after the intervention

• 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.

  Immediately after the intervention

• 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.

  Follow-up up to 24 weeks

• 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.

  Follow-up up to 24 weeks

• PANNS total (for RECOVERYTRSGR)

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

  Pre-intervention

• PANNS total (for RECOVERYTRSGR)

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

  Immediately after the intervention

• PANNS total (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• WHODAS total (for RECOVERYTRSGR)

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

  Pre-intervention

• WHODAS total (for RECOVERYTRSGR)

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

  Immediately after the intervention

• WHODAS total (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• RAS-DS total (for RECOVERYTRSGR)

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

  Pre-intervention

• RAS-DS total (for RECOVERYTRSGR)

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

  Immediately after the intervention

• RAS-DS total (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

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

  Pre-intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

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

  Immediately after the intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

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

  Pre-intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

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

  Immediately after the intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)

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

  Follow-up up to 24 weeks

• SRSDA (for RECOVERYTRSBDGR)

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

  Pre-intervention

• SRSDA (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• SRSDA (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• SRSDA (for RECOVERYTRSBDGR)

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

  Pre-intervention

• SRSDA (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• SRSDA (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• Hamilton Depression Scale (for RECOVERYTRSBDGR)

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

  Pre-intervention

• Hamilton Depression Scale (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• Hamilton Depression Scale (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

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

  Pre-intervention

• Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• The Altman self-rating scale (for RECOVERYTRSBDGR)

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

  Pre-intervention

• The Altman self-rating scale (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• The Altman self-rating scale (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• PSYRAT (for RECOVERYTRSBDGR)

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

  Pre-intervention

• PSYRAT (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• PSYRAT (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• PSYRAT (for RECOVERYTRSBDGR)

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

  Pre-intervention

• PSYRAT (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• PSYRAT (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• WHODAS total (for RECOVERYTRSBDGR)

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

  Pre-intervention

• WHODAS total (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• WHODAS total (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• RAS-DS Total (for RECOVERYTRSBDGR)

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

  Pre-intervention

• RAS-DS Total (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• RAS-DS Total (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

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

  Pre-intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

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

  Pre-intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

• The Young mania rating scale (for RECOVERYTRSBDGR)

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

  Pre-intervention

• The Young mania rating scale (for RECOVERYTRSBDGR)

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

  Immediately after the intervention

• The Young mania rating scale (for RECOVERYTRSBDGR)

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

  Follow-up up to 24 weeks

Secondary Outcomes (2)

• WAIS (for RECOVERYTRSGR)

  Pre-intervention

• WAIS (for RECOVERYTRSBDGR)

  Pre-intervention

Study Arms (4)

Group A

EXPERIMENTAL

Pharmacotherapy and RECOVERYTRSGR 22 participants

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

Group B

ACTIVE COMPARATOR

Pharmacotherapy and TAU. 20 participants

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

Group C

EXPERIMENTAL

Pharmacotherapy and RECOVERYTRSBDGR. 22 participants

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

Group D

ACTIVE COMPARATOR

Pharmacotherapy and TAU. 20 participants

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

Interventions

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 C

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 A

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 B

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

Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65
• IQ ≥ 80
• Diagnosis TRS.
• age 18-65
• IQ ≥ 80
• Diagnosis TRSBD.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Stavroula Rakitzi: lead

Study Sites (1)

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

Athens, 15771, Greece

Location

Related Publications (21)

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  BACKGROUND

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant

Interventions

Clozapine; Olanzapine; Aripiprazole; Risperidone; asenapine; Paliperidone Palmitate; Clopenthixol; Drug Therapy; Clonazepam; oxybutynin; Antidepressive Agents; Psychotherapy; Lithium; Valproic Acid; Citalopram

Condition Hierarchy (Ancestors)

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Piperazines; Heterocyclic Compounds, 1-Ring; Quinolones; Quinolines; Pyrimidinones; Pyrimidines; Isoxazoles; Azoles; Thioxanthenes; Sulfur Compounds; Organic Chemicals; Xanthenes; Therapeutics; Benzodiazepinones; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Behavioral Disciplines and Activities; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids; Propylamines; Amines; Nitriles; Benzofurans

Study Officials

• Dr. Stavroula Rakitzi, PhD

  Private Practice

  STUDY DIRECTOR

• Dr. Polyxeni Georgila, M. D.

  Private Practice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: 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).

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: July 2, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)