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)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients with treatment resistant schizophrenia:
- •age 18-65
- •Diagnosis TRS.
- •Inclusion criteria for patients with treatment resistant bipolar disorder:
- •age 18-65
- •Diagnosis TRSBD.
排除标准
- •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.
研究组 & 干预措施
Group A
Pharmacotherapy and RECOVERYTRSGR 22 participants
干预措施: Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram), (Combination Product)
Group B
Pharmacotherapy and TAU. 20 participants
干预措施: Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants, (Combination Product)
Group C
Pharmacotherapy and RECOVERYTRSBDGR. 22 participants
干预措施: Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine (Combination Product)
Group D
Pharmacotherapy and TAU. 20 participants
干预措施: Group D (Pharmacotherapy and TAU)Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, seropram, lithium, depakine) (Combination Product)
结局指标
主要结局
MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
WHODAS total (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures functional outcome. Minimum 0, maximum 100. Low scores better.
The Young mania rating scale (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures mania. Minimum 0, maximum 60. Low scores better
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)
时间窗: 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.
PANNS total (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
WHODAS total (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures depression. Minimum 0, maximum 60. Low scores better.
MCCB BACS symbol coding (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)
时间窗: 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
MCCB Brief visuospatial memory test (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Title (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures social cognition. Minimum 0, maximum 12. high scores better.
RAS-DS Total (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures recovery. Minimum 0, maximum 152. High scores better
Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures social cognition. Minimum 0, maximum 67. high scores better.
Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures social cognition. Minimum 0, maximum 12. high scores better.
Hamilton Depression Scale (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It meaasures depression. Minimum 0, maximum 23. Low scores better.
RAS-DS total (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It measures recovery. Minimum 0, maximum 152. High scores better.
The Altman self-rating scale (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)
时间窗: 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.
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)
时间窗: Follow-up up to 24 weeks
It. measures severity of illness. Minimum 0, Maximum 7, low scores better.
SRSDA (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
PSYRAT (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)
时间窗: Follow-up up to 24 weeks
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
MCCB BACS symbol coding (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB BACS symbol coding (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Wechsler memory scale-spatial span (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better. Summary of forward and backward total score
MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Neurospychological Assessment Battery (NAB) (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Brief visuospatial memory test (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.
MCCB Brief visuospatial memory test (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures social cognition. Minimum 0, maximum 67. high scores better.
Social Perception Scale (SPS) Stimuli (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures social cognition. Minimum 0, maximum 67. high scores better.
Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures social cognition. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Interpretation (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures social cognition. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Title (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures social cognition. Minimum 0, maximum 12. high scores better.
Social Perception Scale (SPS) Title (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures social cognition. Minimum 0, maximum 12. high scores better.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSGR)
时间窗: 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.
The Greek verbal memory test (Kosmidou & Vlahou, 2010) (for RECOVERYTRSBDGR)
时间窗: 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.
PANNS total (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
PANNS total (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
WHODAS total (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures recovery. Minimum 0, maximum 152. High scores better.
RAS-DS total (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It measures recovery. Minimum 0, maximum 152. High scores better.
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)
时间窗: Pre-intervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSGR)
时间窗: Immediately after the intervention
It. measures severity of illness. Minimum 0, Maximum 7, low scores better.
SRSDA (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
Hamilton Depression Scale (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It meaasures depression. Minimum 0, maximum 23. Low scores better.
Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures depression. Minimum 0, maximum 60. Low scores better.
Montgomery and Asperg depression scale (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures depression. Minimum 0, maximum 60. Low scores better.
The Altman self-rating scale (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Altman self-rating scale (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
PSYRAT (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 44. Low scores better.
PSYRAT (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
WHODAS total (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures functional outcome. Minimum 0, maximum 100. Low scores better.
WHODAS total (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures functional outcome. Minimum 0, maximum 100. Low scores better.
RAS-DS Total (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures recovery. Minimum 0, maximum 152. High scores better
RAS-DS Total (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures recovery. Minimum 0, maximum 152. High scores better
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI) (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Young mania rating scale (for RECOVERYTRSBDGR)
时间窗: Pre-intervention
It measures mania. Minimum 0, maximum 60. Low scores better
The Young mania rating scale (for RECOVERYTRSBDGR)
时间窗: Immediately after the intervention
It measures mania. Minimum 0, maximum 60. Low scores better
次要结局
- WAIS (for RECOVERYTRSGR)(Pre-intervention)
- WAIS (for RECOVERYTRSBDGR)(Pre-intervention)
研究者
Dr. Stavroula Rakitzi
Director
Rakitzi, Stavroula